scholarly journals Dalfampridine in the treatment of multiple sclerosis: a meta-analysis of randomised controlled trials

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Enyao Zhang ◽  
Xin Tian ◽  
Ruoming Li ◽  
Chaoyang Chen ◽  
Min Li ◽  
...  

Abstract Background Multiple sclerosis (MS) is a chronic illness involving the central nervous system (CNS) that is characterised by inflammation, demyelination, and degenerative changes. Dalfampridine is one of the available treatments for MS symptoms and comorbidities. This meta-analysis aimed to assess the safety and benefits of dalfampridine versus placebo in MS by summarising data deriving from previously published clinical randomised controlled studies (RCTs). Results A total of 9 RCTs were included in this meta-analysis, involving 1691 participants. There were significant differences between dalfampridine and placebo in terms of decreased 12-item Multiple Sclerosis Walking Scale score (weighted mean difference [WMD] =  − 3.68, 95% confidence interval [CI] [− 5.55, − 1.80], p = 0.0001), improved response to the timed 25-foot walk test (relative risk [RR] = 2.57, 95% CI [1.04, 6.33], p = 0.04), increased 6-min walk test (WMD = 18.40, 95% CI [1.30, 35.51], p = 0.03), increased 9-Hole Peg Test score (WMD = 1.33, 95% CI [0.60, 2.05], p = 0.0004), and increased Symbol Digit Modalities Test score (WMD = 4.47, 95% CI [3.91, 5.02], p < 0.00001). Significant differences in the incidence of side effects were also observed (RR = 1.12, 95% CI [1.04, 1.21], p = 0.002). Conclusion Dalfampridine exerts positive effects on walking ability, finger dexterity, and cognitive function. Treatment should be administered under the guidance of a physician or pharmacist given the higher incidence of adverse events.

2013 ◽  
Vol 110 (7) ◽  
pp. 1178-1187 ◽  
Author(s):  
Nassib Bezerra Bueno ◽  
Ingrid Sofia Vieira de Melo ◽  
Suzana Lima de Oliveira ◽  
Terezinha da Rocha Ataide

The role of very-low-carbohydrate ketogenic diets (VLCKD) in the long-term management of obesity is not well established. The present meta-analysis aimed to investigate whether individuals assigned to a VLCKD (i.e. a diet with no more than 50 g carbohydrates/d) achieve better long-term body weight and cardiovascular risk factor management when compared with individuals assigned to a conventional low-fat diet (LFD; i.e. a restricted-energy diet with less than 30 % of energy from fat). Through August 2012, MEDLINE, CENTRAL, ScienceDirect, Scopus, LILACS, SciELO, ClinicalTrials.gov and grey literature databases were searched, using no date or language restrictions, for randomised controlled trials that assigned adults to a VLCKD or a LFD, with 12 months or more of follow-up. The primary outcome was body weight. The secondary outcomes were TAG, HDL-cholesterol (HDL-C), LDL-cholesterol (LDL-C), systolic and diastolic blood pressure, glucose, insulin, HbA1c and C-reactive protein levels. A total of thirteen studies met the inclusion/exclusion criteria. In the overall analysis, five outcomes revealed significant results. Individuals assigned to a VLCKD showed decreased body weight (weighted mean difference − 0·91 (95 % CI − 1·65, − 0·17) kg, 1415 patients), TAG (weighted mean difference − 0·18 (95 % CI − 0·27, − 0·08) mmol/l, 1258 patients) and diastolic blood pressure (weighted mean difference − 1·43 (95 % CI − 2·49, − 0·37) mmHg, 1298 patients) while increased HDL-C (weighted mean difference 0·09 (95 % CI 0·06, 0·12) mmol/l, 1257 patients) and LDL-C (weighted mean difference 0·12 (95 % CI 0·04, 0·2) mmol/l, 1255 patients). Individuals assigned to a VLCKD achieve a greater weight loss than those assigned to a LFD in the long term; hence, a VLCKD may be an alternative tool against obesity.


BMJ ◽  
2019 ◽  
pp. l1328 ◽  
Author(s):  
Giovanni Musso ◽  
Roberto Gambino ◽  
Maurizio Cassader ◽  
Elena Paschetta

AbstractObjectiveTo assess the efficacy and safety of dual sodium glucose cotransporter (SGLT) 1/2 inhibitor sotagliflozin in type 1 diabetes mellitus.DesignMeta-analysis of randomised controlled trials.Data sourcesMedline; Cochrane Library; Embase; international meeting abstracts; international and national clinical trial registries; and websites of US, European, and Japanese regulatory authorities, up to 10 January 2019.Eligibility criteria for selecting studiesRandomised controlled trials evaluating the effect of sotagliflozin versus active comparators or placebo on glycaemic and non-glycaemic outcomes and on adverse events in type 1 diabetes in participants older than 18. Three reviewers extracted data for study characteristics, outcomes of interest, and risk of bias and summarised strength of evidence using the grading of recommendations assessment, development, and evaluation approach. Main outcomes were pooled using random effects models.ResultsOf 739 records identified, six randomised placebo controlled trials (n=3238, duration 4-52 weeks) were included. Sotagliflozin reduced levels of glycated haemoglobin (HbA1c; weighted mean difference −0.34% (95% confidence interval −0.41% to −0.27%), P<0.001); fasting plasma glucose (−16.98 mg/dL, −22.1 to −11.9; 1 mg/dL=0.0555 mmol/L) and two hour-postprandial plasma glucose (−39.2 mg/dL, −50.4 to −28.1); and daily total, basal, and bolus insulin dose (−8.99%, −10.93% to −7.05%; −8.03%, −10.14% to −5.93%; −9.14%, −12.17% to −6.12%; respectively). Sotagliflozin improved time in range (weighted mean difference 9.73%, 6.66% to 12.81%) and other continuous glucose monitoring parameters, and reduced body weight (−3.54%, −3.98% to −3.09%), systolic blood pressure (−3.85 mm Hg, −4.76 to −2.93), and albuminuria (albumin:creatinine ratio −14.57 mg/g, −26.87 to −2.28). Sotagliflozin reduced hypoglycaemia (weighted mean difference −9.09 events per patient year, −13.82 to −4.36) and severe hypoglycaemia (relative risk 0.69, 0.49 to 0.98). However, the drug increased the risk of ketoacidosis (relative risk 3.93, 1.94 to 7.96), genital tract infections (3.12, 2.14 to 4.54), diarrhoea (1.50, 1.08 to 2.10), and volume depletion events (2.19, 1.10 to 4.36). Initial HbA1c and basal insulin dose adjustment were associated with the risk of diabetic ketoacidosis. A sotagliflozin dose of 400 mg/day was associated with a greater improvement in most glycaemic and non-glycaemic outcomes than the 200 mg/day dose, without increasing the risk of adverse events. The quality of evidence was high to moderate for most outcomes, but low for major adverse cardiovascular events and all cause death. The relatively short duration of trials prevented assessment of long term outcomes.ConclusionsIn type 1 diabetes, sotagliflozin improves glycaemic and non-glycaemic outcomes and reduces hypoglycaemia rate and severe hypoglycaemia. The risk of diabetic ketoacidosis could be minimised by appropriate patient selection and down-titration of the basal insulin dose.


2005 ◽  
Vol 23 (2) ◽  
pp. 70-76 ◽  
Author(s):  
Yoshito Mukaino ◽  
Jongbae Park ◽  
Adrian White ◽  
Edzard Ernst

Objective To summarise the existing evidence on acupuncture as a therapy for depression. Methods RCTs were included, in which either manual acupuncture or electroacupuncture was compared with any control procedure in subjects with depression. Data were extracted independently by two authors. The methodological quality was assessed. Pre and post means and SDs for depression specific measures were extracted, when available, for meta-analysis. Results Seven randomised comparative trials involving 509 patients were included. The evidence is inconsistent on whether manual acupuncture is superior to sham, and suggests that acupuncture was not superior to waiting list. Evidence suggests that the effect of electroacupuncture may not be significantly different from antidepressant medication, weighted mean difference −0.43(95% CI −5.61 to 4.76). There is inconclusive evidence on whether acupuncture has an additive effect when given as an adjunct to antidepressant drugs. Conclusion The evidence from controlled trials is insufficient to conclude whether acupuncture is an effective treatment for depression, but justifies further trials of electroacupuncture.


2015 ◽  
Vol 22 (3) ◽  
pp. 373-384 ◽  
Author(s):  
Sofia Straudi ◽  
Chiara Fanciullacci ◽  
Carlotta Martinuzzi ◽  
Claudia Pavarelli ◽  
Bruno Rossi ◽  
...  

Background: Gait and mobility impairments are common in progressive multiple sclerosis (MS), leading to reduced quality of life (QoL). Objective: In this randomized controlled study, we tested the effects of robot-assisted gait training (RAGT) and compared it to conventional physiotherapy, measuring walking ability, depression, fatigue, and QoL in patients with progressive MS and severe gait disability. Methods: Fifty-two participants (Expanded Disability Status Scale score 6–7) completed the study protocol. They received two sessions/week over 6 weeks of RAGT or conventional walking therapy. Outcome measures were Six-Minute Walk Test, Ten-Meter Walk Test, Timed Up and Go Test, Berg Balance Scale, Fatigue Severity Scale, Patient Health Questionnaire, and Short Form 36. They were performed pre-treatment, post-treatment, and at 3 months. Results: Walking endurance ( p < 0.01) and balance ( p < 0.01) were improved among those in the RAGT group. Positive effects on depression in both treatment groups were highlighted. However, only among those in the RAGT group was perceived physical functioning QoL increased. No significant effects on fatigue were found. Conclusion: RAGT is a treatment option in progressive MS patients with severe gait impairments to induce short-lasting effects on mobility and QoL.


2020 ◽  
Vol 15 (1) ◽  
pp. 37-42 ◽  
Author(s):  
Xiaobin Yang ◽  
Haishi Zheng ◽  
Yuan Liu ◽  
Dingjun Hao ◽  
Baorong He ◽  
...  

Aims/Background: Ovariectomy (OVX)-induced murine model is widely used for postmenopausal osteoporosis study. Our current study was conducted to systematically review and essentially quantified the bone mass enhancing effect of puerarin on treating OVX-induced postmenopausal osteoporosis in murine model. Methods: Literatures from PUBMED, EMBASE, and CNKI were involved in our searching strategy by limited the inception date to January 9th, 2019. Moreover, the enhancing effect of puerarin on bone mass compared to OVX-induced rats is evaluated by four independent reviewers. Finally, all the data were extracted, quantified and analyzed via RevMan, besides that in our current review study, we assessed the methodological quality for each involved study. Results: Based on the searching strategy, eight randomization studies were finally included in current meta-analysis and systematic review. According to the data analysis by RevMan, puerarin could improve bone mineral density (BMD); (eight studies, n=203; weighted mean difference, 0.05; 95% CI, 0.03-0.07; P<0.0001) using a random-effects model. There is no significant difference between puerarin and estrogen (seven studies, n=184; weighted mean difference, 0.00; 95% CI, -0.01 to 0.00; P=0.30). Conclusions: Puerarin showed upregulating effects on bone mass in OVX-induced postmenopausal osteoporosis in murine model. More studies of the effect of puerarin on bone density in OVX animals are needed.


2021 ◽  
Vol 49 (7) ◽  
pp. 030006052110327
Author(s):  
Weihua Liu ◽  
Wenli Yu ◽  
Hongli Yu ◽  
Mingwei Sheng

Objective To compare the clinical efficacy and safety of dexmedetomidine and propofol in patients who underwent gastrointestinal endoscopy. Methods Relevant studies comparing dexmedetomidine and propofol among patients who underwent gastrointestinal endoscopy were retrieved from databases such as PubMed, Embase, and Cochrane Library. Results Seven relevant studies (dexmedetomidine group, n = 238; propofol group, n = 239) met the inclusion criteria. There were no significant differences in the induction time (weighted mean difference [WMD] = 3.46, 95% confidence interval [CI] = −0.95–7.88, I2 = 99%) and recovery time (WMD = 2.74, 95% CI = −2.72–8.19, I2 = 98%). Subgroup analysis revealed no significant differences in the risks of hypotension (risk ratio [RR] = 0.56, 95% CI = 0.25–1.22) and nausea and vomiting (RR = 1.00, 95% CI = 0.46–2.22) between the drugs, whereas dexmedetomidine carried a lower risk of hypoxia (RR = 0.26, 95% CI = 0.11–0.63) and higher risk of bradycardia (RR = 3.01, 95% CI = 1.38–6.54). Conclusions Dexmedetomidine had similar efficacy and safety profiles as propofol in patients undergoing gastrointestinal endoscopy.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
S Dulal ◽  
A Prost ◽  
N Saville ◽  
S Karki ◽  
D Merom

Abstract Background We did a systematic review to understand: (a) the effects of integrated versus usual care on the developmental outcomes and nutritional status of children under five years; and (b) which intervention characteristics are associated with positive effects. Methods We searched eight electronic databases for studies published between January 2013 and September 2019. Eligible studies were Randomised Controlled Trials (RCTs) and non-randomised controlled studies of integrated nutrition and stimulation interventions with child growth and developmental outcomes. We extracted data on intervention characteristics including delivery strategies, behaviour change techniques, intervention intensity and delivery personnel. We meta-analysed data for Length-for-age/Height-for-age Z scores (LAZ/HAZ) and cognitive, motor and language development scores, and conducted subgroup analyses by main intervention characteristics. Results Twenty-two unique RCTs met the inclusion criteria, of which 16 were included in the meta-analysis. Compared to the usual care, pooled Effect Sizes (ES) showed small to medium benefits of integrated interventions on cognitive (n = 15, ES 0.64; 95% CI: 0.39, 0.88) and language development scores (n = 10, ES 0.47, 95% CI: 0.21, 0.73) but heterogeneity was high (I2&gt;75%). We found no significant effects of interventions on motor development scores (n = 12, ES 0.31, 95% CI: -0.02, 0.64) or LAZ/HAZ scores (n = 8, ES -0.03, 95% CI: -0.11, 0.03). The effects of interventions on developmental outcomes did not differ by intervention characteristics, and heterogeneity remained high in sub-group analyses. Conclusions Integrated nutrition and stimulation interventions had significant effects on cognitive and language development, but no detectable effect on motor development or linear growth. Our ability to identify intervention characteristics linked to positive effects can be improved by standardising the reporting of implementation processes. Key messages More high-quality trials with longer follow-up duration are needed to examine the role of integrated nutrition and stimulation interventions on growth and developmental outcomes. Future research should map the characteristics of integrated nutrition and stimulation interventions following standardised guidelines to understand their influence on the outcomes reported.


2021 ◽  
Vol 12 ◽  
Author(s):  
Dong Wang ◽  
Zhen Ruan ◽  
Rongchao Zhang ◽  
Xuejing Wang ◽  
Ruihui Wang ◽  
...  

Background: Earthworm, also called dilong (Chinese language), has been used as a traditional Chinese medicine for thousands of years. Recently, some scientists believe that earthworm extracts (EE) can promote wound healing. However, its effectiveness remains controversial. We conducted a meta-analysis to evaluate the effect of EE on wound healing based on the healing rate.Methods: We comprehensively reviewed literature that mentioned EE for wound healing in the PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), VIP database for Chinese Technical Periodicals, and WanFang database that have been published until January 2021. We computed weighted mean difference (WMD) for analysis with RevMan 5.3 software in animal and human models groups. Two researchers independently selected studies and evaluated the risk of bias with the Cochrane Collaboration tool. The quality of the evidence was assessed with the Cochrane risk of bias tool. This study is registered on PROSPERO (CRD42020168400).Results: From 2,486 articles, we selected 16 studies for analysis. EE treatment was associated with improvements in wound healing performance based on wound healing rate (mouse model: weighted mean difference (WMD) = 3.55, 95% confidence interval (CI): 2.34–4.77, p &lt; 0.00001; rat model: WMD = 17.29, 95% CI: 5.75–28.82, p = 0.003; rabbit model: WMD = 19.29, 95% CI: 9.95–28.64, p &lt; 0.0001). Clinical studies also confirmed that EE could reduce healing time in hospital (WMD = −8.94, 95% CI: −17.75 to −0.14, p = 0.05).Conclusion: The results of this meta-analysis demonstrated the efficacy of EE on wound healing process. As a corollary, EE can be a useful natural product for wound healing drug development.Systematic Review Registration:https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=168400, identifier CRD42020168400.


2008 ◽  
Vol 23 (6) ◽  
pp. 520-530 ◽  
Author(s):  
Suzana Angélica Silva Lustosa ◽  
Humberto Saconato ◽  
Álvaro Nagib Atallah ◽  
Gaspar de Jesus Lopes Filho ◽  
Delcio Matos

PURPOSE: To compare morbidity, mortality, recurrence and 5-year survival between D1 and D2 or D3 for treatment of gastric cancer. METHODS: Systematic review and meta-analysis of RCTs. Metaview in RevMan 4.2.8 for analysis; statistical heterogeneity by Cochran's Q test (P<0.1) and I² test (P>50%). Estimates of effect were calculated using random effects model. RESULTS: D2 or D3 was associated with higher in-hospital mortality, with RR = 2.13, p=0.0004, 95% CI, 1.40 to 3.25, I²=0%, P=0.63; overall morbidity showed higher incidence in D2 or D3, RR = 1.98, p<0.00001, 95% CI, 1.64 to 2.38, I² = 33.9%, P=0.20; operating time showed longer duration in D2 or D3, weighted mean difference of 1.05, p<0.00001, 95% CI, 0.71 to 1.38, I² = 78.7%, P=0.03, with significant statistical heterogeneity; reoperation showed higher rate in D2 or D3, with RR = 2.33, p<0.0001, 95% CI, 1.58 to 3.44, I² = 0%, P=0.99; hospital stay showed longer duration in the D2 or D3, with weighted mean difference of 4.72, p<0.00001, 95% CI, 3.80 to 5.65, I² = 89.9%, P<0.00001; recurrence was analyzed showed lower rate in D2 or D3, with RR = 0.89, p=0.02, 95% CI, 0.80 to 0.98, I² = 71.0%, P = 0.03, with significant statistical heterogeneity; mortality with recurrent disease showed higher incidence in D1, with RR = 0.88, p=0.04, 95% CI, 0.78 to 0.99, I² =51.8%, P=0.10; 5-year survival showed no significant difference, with RR = 1.05, p=0.40, 95% CI, 0.93 to 1.19, I² = 49.1% and P=0.12. CONCLUSIONS: D2 or D3 lymphadenectomy procedure is followed by higher overall morbidity and higher in-hospital mortality; D2 or D3 lymphadenectomy shows lower incidence of recurrence and lower mortality with recurrent disease, when analysed altogether with statistical heterogeneity; D2 or D3 lymphadenectomy has no significant impact on 5-year survival.


2021 ◽  
Vol 8 ◽  
Author(s):  
Tianyi Zhang ◽  
Chengyang Xu ◽  
Rui Zhao ◽  
Zhipeng Cao

Biomarkers such as B-type natriuretic peptide (BNP), N-terminal pro-BNP (NT-proBNP), cardiac troponin (cTn), and CK-MB contribute significantly to the diagnosis of cardiovascular disease (CVD). Recent studies have demonstrated that suppression of tumorigenicity 2 (ST2) is associated with CVD, but a meta-analysis of ST2 levels in different CVDs has yet to be conducted. Therefore, the present study aimed to investigate soluble ST2 (sST2) levels in patients with ischemic heart disease (IHD), myocardial infarction (MI), and heart failure (HF). A total of 1,425 studies were searched across four databases, of which 16 studies were included in the meta-analysis. The Newcastle–Ottawa Quality Assessment Scale (NOS) values of all 16 studies were ≥7. The meta-analysis results indicated that the sST2 level was not correlated with IHD (standard mean difference [SMD] = 0.58, 95% confidence interval [95% CI] = 0.00 to 1.16, p = 0.05) or MI (weighted mean difference [WMD] = 0.17, 95% CI = −0.22 to 0.55, p = 0.40) but was significantly associated with HF (WMD = 0.21, 95% CI = 0.04 to 0.38, p = 0.02; I2 = 99%, p &lt; 0.00001). sST2 levels did not differ significantly between patients with IHD or MI and healthy individuals; however, we believe that ST2 could be used as an auxiliary diagnostic biomarker of HF.


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