scholarly journals Randomised controlled trials of antidepressant and anti-anxiety medications for people with autism spectrum disorder: systematic review and meta-analysis

BJPsych Open ◽  
2021 ◽  
Vol 7 (6) ◽  
Author(s):  
Shoumitro Deb ◽  
Meera Roy ◽  
Rachel Lee ◽  
Madiha Majid ◽  
Bharati Limbu ◽  
...  

Background Although widely used, the current evidence for the efficacy of antidepressant and anti-anxiety medications for people with autism spectrum disorder (ASD) is limited and conflicting. Aims We carried out a systematic review and meta-analysis of randomised controlled trials that assessed the effectiveness of these medications in people with ASD. Method We searched the following databases: Cochrane Library, Medline, EMBASE, CINAHL, PsycINFO, ERIC, DARE and ClinicalTrials.gov. Additionally, we hand-searched 11 relevant journals. We used the Cochrane risk-of-bias tool and Jadad score to assess the quality of each included study. We carried out a meta-analysis using a random effects model. Results We included 15 randomised controlled trials (13 on antidepressants and two on anti-anxiety medications) for a total of 958 people with ASD. Data showed contradictory findings among the studies, with larger studies mostly showing a non-significant difference in outcomes between the treatment and the placebo groups. Meta-analysis of pooled Yale-Brown Obsessive Compulsive Scale and Clinical Global Impression Scale data from nine studies (60%) did not show any statistically significant inter-group difference on either of the outcome measures. The adverse effects reported were mild and, in most studies, their rates did not show any significant inter-group difference. Conclusions Given the methodological flaws in the most included studies and contradictory findings, it is difficult to draw any definitive conclusion about the effectiveness of either antidepressant or anti-anxiety medications to treat either ASD core symptoms or associated behaviours. Robust, large-scale, randomised controlled trials are needed to address this issue.

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e047344
Author(s):  
Qingwu Wu ◽  
Lianxiong Yuan ◽  
Huijun Qiu ◽  
Xinyue Wang ◽  
Xuekun Huang ◽  
...  

ObjectivesTo assess the efficacy and safety of omalizumab for chronic rhinosinusitis with nasal polyps (CRSwNP) and to identify evidence gaps that will guide future research on omalizumab for CRSwNP.DesignSystematic review and meta-analysis.Data sourcesA comprehensive search was performed in PubMed, Embase, Web of Science and the Cochrane Library on 13 October 2020.Eligibility criteriaRandomised controlled trials (RCTs) comparing omalizumab with placebo, given for at least 16 weeks in adult patients with CRSwNP.Data extraction and synthesisTwo independent authors screened search results, extracted data and assessed studies using the Cochrane risk of bias tool. Data were pooled using the inverse-variance method and expressed as mean differences (MDs) with 95% CIs. Heterogeneity was assessed by the χ2 test and the I2 statistic.ResultsA total of four RCTs involving 303 participants were identified. When comparing omalizumab to placebo, there was a significant difference in Nasal Polyps Score (MD=−1.20; 95% CI −1.48 to −0.92), Nasal Congestion Score (MD=−0.67; 95% CI −0.86 to −0.48), Sino-Nasal Outcome Test-22 (MD=−15.62; 95% CI −19.79 to −11.45), Total Nasal Symptom Score (MD=−1.84; 95% CI −2.43 to −1.25) and reduced need for surgery (risk ratio (RR)=5.61; 95% CI 1.99 to 15.81). Furthermore, there was no difference in the risk of serious adverse events ((RR=1.40; 95% CI 0.29 to 6.80), adverse events (RR=0.83; 95% CI 0.60 to 1.15) and rescue systemic corticosteroid (RR=0.52; 95% CI 0.17 to 1.61).ConclusionsThis was the first meta-analysis that identified omalizumab significantly improved endoscopic, clinical and patient-reported outcomes in adults with moderate to severe CRSwNP and it was safe and well tolerated.PROSPERO registration numberCRD42020207639.


F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 48
Author(s):  
Pablo Daniel Estrella Porter ◽  
Luis Eduardo Guzmán Freire ◽  
Joseth Paulina Adatty Molina ◽  
María Verónica Burneo Raza ◽  
Henry Alejandro Carrión Celi ◽  
...  

Background: Autism spectrum disorder (ASD) is a neurodevelopmental condition associated with an unclear etiologic mechanism. Following suggestions in the literature of a close relation between the gut microbiota and the central nervous system development, neuroimmune and neuroendocrine systems, new theories and strategies of the management of ASD in children focus on the brain-gut axis via microbiota transfer therapy. Despite the regular appearance in the news, the level of evidence supporting this intervention is unclear and to this date, no systematic review on this issue has been published. Methods: We conducted a systematic literature review of the efficacy and safety of microbiota transfer therapy for the management of ASD in children. MEDLINE via PubMed, LILACS IBECS via BVS, EMBASE via Ovid, Scopus and Cochrane Library were searched on 19th April 2018. Results: One single study published in 2017 was identified. The intervention group included 18 patients and showed significant clinical improvements in the gastrointestinal and ASD-related symptoms. The clinical procedure was reported as safe and well-tolerated with some transitory adverse effects. Conclusions: The causality and correlation of the intervention and the expected outcomes cannot be assumed with current evidence. In addition, recommendations about the effectiveness or safety of microbiota transfer therapy in children with ASD cannot be currently issued. Randomized controlled trials and clinical protocols for the intervention are needed.


BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022348 ◽  
Author(s):  
Ye-Xuan Cao ◽  
Sha Li ◽  
Hui-Hui Liu ◽  
Jian-Jun Li

ObjectiveTo evaluate the potential effects of proprotein convertase subtilisin/kexin type 9 monoclonal antibody (PCSK9-mAb) on high-sensitivity C reactive protein (hs-CRP) concentrations.DesignA systematic review and meta-analysis of randomised controlled trials.Data sourcesPubMed, MEDLINE, the Cochrane Library databases, ClinicalTrials.gov and recent conferences were searched from inception to May 2018.Eligibility criteria for selecting studiesAll randomised controlled trials that reported changes of hs-CRP were included.ResultsTen studies involving 4198 participants were identified. PCSK9-mAbs showed a slight efficacy in reducing hs-CRP (−0.04 mg/L, 95% CI: −0.17 to 0.01) which was not statistically different. The results did not altered when subgroup analyses were performed including PCSK9-mAb types (alirocumab: 0.12 mg/L, 95% CI: −0.18 to 0.43; evolocumab: 0.00 mg/L, 95% CI: −0.07 to 0.07; LY3015014: −0.48 mg/L, 95% CI: −1.28 to 0.32; RG7652: 0.35 mg/L, 95% CI: −0.26 to 0.96), treatment duration (≤12w: 0.00 mg/L, 95% CI: −0.07 to 0.07; >12w: −0.11 mg/L, 95% CI: −0.45 to −0.23), participant characteristics (familial hypercholesterolaemia: 0.00 mg/L, 95% CI: −0.07 to 0.07; non-familial hypercholesterolaemia: 0.07 mg/L, 95% CI: −0.12 to 0.26; mix: −0.48 mg/L, 95% CI: −1.28 to 0.32) and treatment methods (monotherapy: 0.00 mg/L, −0.08 to 0.07; combination therapy: −0.08 mg/L, −0.37 to 0.21). Meta-regression analyses suggested no significant linear correlation between baseline age (p=0.673), sex (p=0.645) and low-density lipoprotein cholesterol reduction (p=0.339).ConclusionsOur updated meta-analysis suggested that PCSK9-mAbs had no significant impact on circulating hs-CRP levels irrespective of PCSK9-mAb types, participant characteristics and treatment duration or methods.


2019 ◽  
Vol 96 (1134) ◽  
pp. 197-205 ◽  
Author(s):  
Mehdi Koushki ◽  
Mostafa Lakzaei ◽  
Hadi Khodabandehloo ◽  
Hossein Hosseini ◽  
Reza Meshkani ◽  
...  

BackgroundResveratrol is a naturally occurring polyphenol compound mainly found in grapes and red wine. The evidence has suggested that resveratrol has an antioxidant effect. However, the results are inconsistent and inconclusive. Thus, we conducted a systematic review and meta-analysis to evaluate the effect of resveratrol supplementation on markers of oxidative stress.MethodsWe searched PubMed, ISI Web of Science, EMBASE, Scopus and the Cochrane library up to December 2018 to identify randomised controlled trials (RCTs) assessing resveratrol supplementation effects on oxidative markers. Heterogeneity, publication bias, risk of bias and subgroup analysis were analysed. This meta-analysis was conducted in accordance with the guidelines of the Preferred ReportingItems for Systematic Reviews and Meta-Analysis (PRISMA).ResultsMeta-analysis of data from 12 RCTs did not support significant effect of resveratrol supplementation on circulating levels of superoxide dismutase (SOD) (standardized mean difference (SMD) (1.12), (95% CI −0.91 to 3.1), p=0.28), catalase (CAT) (SMD (−0.07), (95% CI −1.4 to 1.3), p=0.92) and glutathione peroxidase (GPx) (SMD (−0.76), (95% CI −2.56 to 1.04), p=0.40). Although, resveratrol supplementation increased significantly circulating total antioxidant capacity (TAC) concentrations (SMD (0.52), (95% CI −0.02 to 1.07), p=0.05). Severe heterogeneity was observed between studies, and no obvious publication bias was observed in included RCTs.ConclusionCollectively, our findings of available RCTs did no show any benefit of resveratrol supplementation on SOD, CAT and GPx except for TAC. Well-designed RCTs are necessary to confirm these results.


Hernia ◽  
2019 ◽  
Vol 23 (6) ◽  
pp. 1093-1103 ◽  
Author(s):  
P. Gavriilidis ◽  
R. J. Davies ◽  
J. Wheeler ◽  
N. de’Angelis ◽  
S. Di Saverio

Abstract Background–purpose Totally extraperitoneal (TEP) endoscopic hernioplasty and Lichtenstein hernioplasty are the most commonly used approaches for inguinal hernia repair. However, current evidence on which is the preferred approach is inconclusive. This updated meta-analysis was conducted to track the accumulation of evidence over time. Methods Studies were identified by a systematic literature search of the EMBASE, PubMed, Cochrane Library, and Google Scholar databases. Fixed- and random-effects models were used to cumulatively assess the accumulation of evidence over time. Results The TEP cohort showed significantly higher rates of recurrences and vascular injuries compared to the Lichtenstein cohort; [Peto Odds ratio (OR) = 1.58 (1.22, 2.04), p = 0.005], [Peto OR = 2.49 (1.05, 5.88), p = 0.04], respectively. In contrast, haematoma formation rate, time to return to usual activities, and local paraesthesia were significantly lower in the TEP cohort compared to the Lichtenstein cohort; [Peto OR = 0.26 (0.16, 0.41), p ≤ 0.001], [mean difference = − 6.32 (− 8.17, − 4.48), p ≤ 0.001], [Peto OR = 0.26 (0.17, 0.40), p ≤ 0.001], respectively. Conclusions This study, which is based on randomised-controlled trials (RCTs) of high quality, showed significantly higher rates of recurrences and vascular injuries in the TEP cohort than in the Lichtenstein cohort. In contrast, rate of postoperative haematoma formation, local paraesthesia, and time to return to usual activities were significantly lower in the TEP cohort than in the Lichtenstein cohort. Future multicentre RCTs with strict adherence to the standards recommended in the Consolidated Standards of Reporting Trials guidelines will shed further light on the topic.


2019 ◽  
Vol 122 (9) ◽  
pp. 1021-1032
Author(s):  
Amir Hadi ◽  
Arman Arab ◽  
Sajjad Moradi ◽  
Ana Pantovic ◽  
Cain C. T. Clark ◽  
...  

AbstractA number of clinical trials have examined the effect of l-arginine on lipid profile in recent years; however, the results remain equivocal. Therefore, the present study aims to summarise and quantitatively examine the available evidence on the effectiveness l-arginine supplementation on lipid parameters using a systematic review and meta-analytic approach. Online databases including PubMed, Scopus, ISI Web of Science, Cochrane Library and Google Scholar were searched up to April 2019 for randomised controlled trials that examined the effect of l-arginine supplementation on lipid profile in adults. Treatment effects were expressed as weighted mean difference (WMD) and the corresponding standard error in concentrations of serum lipids. To estimate the overall effect of l-arginine supplementation, we used the random-effects model. In total, twelve studies were included in the systematic review. The meta-analysis revealed that l-arginine supplementation did not significantly change the concentrations of total cholesterol (WMD: –5·03 mg/dl; 95 % CI –10·78, 0·73; P = 0·08; inconsistency index (I2) = 39·0 %), LDL (WMD: –0·47 mg/dl; 95 % CI –3·61, 2·66; P = 0·76; I2 = 0·0 %), or HDL (WMD: 0·57 mg/dl; 95 % CI –1·28, 2·43; P = 0·54; I2 = 68·4 %). A significant reduction was observed only in serum TAG levels (WMD: –7·04 mg/dl; 95 % CI –11·42, –2·67; P < 0·001; I2 = 0·0 %). This meta-analysis concludes that l-arginine supplementation can significantly reduce blood TAG levels; however, there is insufficient evidence to support its hypocholesterolaemic effects. To draw straightforward conclusions regarding generalised recommendations for l-arginine supplementation for improving lipid profile, there is a need for more well-controlled trials targeting exclusively patients with dyslipidaemia.


BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e034812 ◽  
Author(s):  
Tolesa Bekele ◽  
Patrick Rawstorne ◽  
Bayzidur Rahman

ObjectiveThis study aimed to provide clarification on the benefits of water, sanitation and hygiene (WASH) alone separately and combined with nutrition in improving child growth outcomes.DesignSystematic review and meta-analysis.MethodsWe conducted a systematic review using the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. PubMed, MEDLINE, EMBASE, Scopus, Cochrane Library, Web of Science and Science Direct were searched in May 2018 and last updated in April 2019. We included studies that reported WASH interventions alone separately or combined with nutrition. Fixed and random-effects models were used to estimate pooled effect in mean difference (MD). Heterogeneity and publication bias statistics were performed.ResultsA total of 18 studies were included: 13 cluster randomised controlled trials (RCTs) and 5 non-randomised controlled trials (non-RCTs). Non-RCTs showed effect of WASH interventions alone on height-for-age z-score (HAZ) (MD=0.14; 95% CI 0.08 to 0.21) but RCTs did not. WASH alone of non-RCTs and RCTs that were delivered over 18–60 months indicated an effect on HAZ (MD=0.04; 95% CI 0.01 to 0.08). RCTs showed an effect for children <2 years (MD=0.07; 95% CI 0.01 to 0.13). Non-RCTs of WASH alone and those that included at least two components, improved HAZ (MD=0.15; 95% CI 0.07 to 0.23) but RCTs did not. WASH alone of non-RCTs and RCTs separately or together showed no effect on weight-for-age z-score (WAZ) and weight-for-height z-score (WHZ). Combined WASH with nutrition showed an effect on HAZ (MD=0.13; 95% CI 0.08 to 0.17) and on WAZ (MD=0.09; 95% CI 0.05 to 0.13) and was borderline on WHZ.ConclusionsWASH interventions alone improved HAZ when delivered over 18–60 months and for children <2 years. Combined WASH with nutrition showed a strong effect on HAZ and WAZ and a borderline effect on WHZ. Integrated WASH with nutrition interventions may be effective inimproving child growth outcomes.


Author(s):  
Samantha Betts ◽  
Lana Feichter ◽  
Zoe Kleinig ◽  
Alice O'Connell-Debais ◽  
Henry Thai ◽  
...  

ABSTRACT Traumatic brain injury (TBI) is the most significant cause of death and severe disability following major trauma within Australia. Populations at risk include young adults aged 15 to 34, older adults, and military personnel. The main form of intervention following traumatic brain injury is rehabilitation, which places a large demand on the healthcare system. Telerehabilitation involves interventions delivered via telecommunication, which can improve accessibility and reduce this burden. There have been no systematic reviews conducted on the effectiveness of telerehabilitation in treating traumatic brain injury. Purpose: To examine the effectiveness of telerehabilitation for adults with traumatic brain injury. Methods: A systematic search of Medline, Embase, the Cumulative Index of Nursing and Allied Health Literature (CINAHL), Scopus, The Cochrane Library, OTSeeker and Google Scholar was conducted. Studies were included with participants aged 18 to 64 with traumatic brain injury and receiving telerehabilitation interventions. Methodological quality was assessed using the critical appraisal tools: Critical Appraisal Skills Programme (CASP) checklist for randomised controlled trials, and McMaster Critical Review for Quantitative Studies for non-randomised studies. Results: Three randomised controlled trials, one pseudo-randomised controlled trial, one case-control trial and one pre-post case series were included in this systematic review. Critical appraisal of the included studies revealed overall methodological quality to be moderate. A range of interventions with differing parameters were used as part of telerehabilitation. Collectively, there is some consistent evidence to indicate that telerehabilitation may be equally effective as other forms of care in the delivery of cognitive and psychological interventions, in addressing memory and depressive symptoms for adults with mild to severe traumatic brain injury. However, it is unclear if it is superior to other forms of care. Conclusions: A small number of studies have investigated the effect of telerehabilitation for adults with traumatic brain injury. The current evidence base is limited due to lack of standardised intervention parameters, outcomes measures and robust sample size. Despite these limitations, telerehabilitation may offer a complementary model of care for adults with traumatic brain injury, especially in instances where traditional models of care may not be readily accessible (such as those in rural and remote areas).


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