Adjunctive Peony-Glycyrrhiza decoction for antipsychotic-induced hyperprolactinaemia: a meta-analysis of randomised controlled trials

BackgroundHyperprolactinaemia is a common adverse effect of antipsychotics (APs). The results of Peony-Glycyrrhiza decoction (PGD) as a potentially useful adjunctive treatment for hyperprolactinaemia are inconsistent.AimThis meta-analysis of randomised controlled trials (RCTs) examined the efficacy and safety of adjunctive PGD therapy for AP-induced hyperprolactinaemia.MethodsEnglish (PubMed, Embase, Cochrane Library, PsycINFO) and Chinese (Chinese National Knowledge Infrastructure, Wanfang Data) databases were systematically searched up to 10 June 2018. The inclusion criteria were based on PICOS—Participants: adult patients with schizophrenia; Intervention: PGD plus APs; Comparison: APs plus placebo or AP monotherapy; Outcomes: efficacy and safety; Study design: RCTs. The weighted mean difference (WMD) and risk ratio (RR) along with their 95% CIs were calculated using Review Manager (RevMan) V.5.3 software.ResultsFive RCTs (n=450) were included and analysed. Two RCTs (n=140) were double-blind and four RCTs (n=409) reported ‘random’ assignment with specific description. The PGD group showed a significantly lower serum prolactin level at endpoint than the control group (n=380, WMD: −32.69 ng/mL (95% CI −41.66 to 23.72), p<0.00001, I2=97%). Similarly, the superiority of PGD over the control groups was also found in the improvement of hyperprolactinaemia-related symptoms. No difference was found in the improvement of psychiatric symptoms assessed by the Positive and Negative Syndrome Scale (n=403, WMD: −0.62 (95% CI −2.38 to 1.15), p=0.49, I2=0%). There were similar rates of all-cause discontinuation (n=330, RR 0.93 (95% CI 0.63 to 1.37), p=0.71, I2=0%) and adverse drug reactions between the two groups. According to the Grading of Recommendations Assessment, Development and Evaluation approach, the level of evidence of primary and secondary outcomes ranged from ‘very low’ (14.3%), ‘low’ (42.8%), ‘moderate’ (14.3%), to ‘high’ (28.6%).ConclusionsCurrent evidence supports the adjunctive use of PGD to suppress elevated prolactin and improve prolactin-induced symptoms without significant adverse events in adult patients with AP-induced hyperprolactinaemia. High-quality RCTs with longer duration are needed to confirm these findings.Trial registration number42016037017.

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Efficacy and safety of omalizumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2020-047344 ◽

2021 ◽

Vol 11 (9) ◽

pp. e047344

Author(s):

Qingwu Wu ◽

Lianxiong Yuan ◽

Huijun Qiu ◽

Xinyue Wang ◽

Xuekun Huang ◽

...

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Chronic Rhinosinusitis ◽

Randomised Controlled Trials ◽

Nasal Polyps ◽

Meta Analysis ◽

Cochrane Library ◽

Controlled Trials ◽

Efficacy And Safety ◽

Randomised Controlled

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.

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Total extraperitoneal endoscopic hernioplasty (TEP) versus Lichtenstein hernioplasty: a systematic review by updated traditional and cumulative meta-analysis of randomised-controlled trials

Hernia ◽

10.1007/s10029-019-02049-w ◽

2019 ◽

Vol 23 (6) ◽

pp. 1093-1103 ◽

Cited By ~ 7

Author(s):

P. Gavriilidis ◽

R. J. Davies ◽

J. Wheeler ◽

N. de’Angelis ◽

S. Di Saverio

Keyword(s):

Randomised Controlled Trials ◽

Meta Analysis ◽

Current Evidence ◽

Cochrane Library ◽

Controlled Trials ◽

Vascular Injuries ◽

Lichtenstein Hernioplasty ◽

Randomised Controlled ◽

Haematoma Formation ◽

Over Time

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.

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Effects of different delivering matrices of β-glucan on lipids in mildly hypercholesterolaemic individuals: a meta-analysis of randomised controlled trials

British Journal Of Nutrition ◽

10.1017/s0007114520001610 ◽

2020 ◽

pp. 1-14

Author(s):

Dengfeng Xu ◽

Hechun Liu ◽

Chao Yang ◽

Hui Xia ◽

Da Pan ◽

...

Keyword(s):

Randomised Controlled Trials ◽

Ldl Cholesterol ◽

Meta Analysis ◽

Hdl Cholesterol ◽

Cochrane Library ◽

Control Group ◽

Controlled Trials ◽

Significant Difference ◽

Liquid Products ◽

Randomised Controlled

Abstract β-Glucan has been reported for its health benefits on blood lipids in hypercholesterolaemic individuals for years. However, people have paid little attention to the effects of β-glucan in populations with mild hypercholesterolaemia as well as the various delivering matrices. Our objective was to perform a meta-analysis to analyse the effects of β-glucan with different delivering matrices in mildly hypercholesterolaemic individuals. After conducting a comprehensive search in Web of Science, PubMed, Scopus and Cochrane Library, a total of twenty-one randomised controlled trials involving 1120 participants were identified to measure the pooled effect. The overall results indicated that consuming a dose of ≥3 g/d of β-glucan for at least 3 weeks could significantly reduce total cholesterol (TC) (−0·27 mmol/l, 95 % CI −0·33, −0·21, P < 0·001) and LDL-cholesterol (−0·26 mmol/l, 95% CI −0·32, −0·20, P < 0·001) compared with the control group in mildly hypercholesterolaemic individuals, while no significant difference was observed in TAG (−0·03 mmol/l, 95% CI −0·11, 0·06, P = 0·521) and HDL-cholesterol (0·01 mmol/l, 95% CI −0·03, 0·04, P = 0·777). There was evidence for modest unexplained heterogeneity in the meta-analysis. In conclusion, β-glucan can significantly reduce risk factors like TC and LDL-cholesterol for CVD in mildly hypercholesterolaemic individuals; furthermore, it appears that the effects of food matrices with both ‘solid products’ and ‘liquid products’ where β-glucan was incorporated into were ranked as the best way to exert its beneficial properties, while ‘liquid’ and ‘solid’ products were ranked as the second and third positions, respectively.

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Efficacy and Adverse Effects of Atropine for Myopia Control in Children: A Meta-Analysis of Randomised Controlled Trials

Journal of Ophthalmology ◽

10.1155/2021/4274572 ◽

2021 ◽

Vol 2021 ◽

pp. 1-12

Author(s):

ChunWen Chen ◽

JingYan Yao

Keyword(s):

Randomised Controlled Trials ◽

Meta Analysis ◽

Rebound Effect ◽

Cochrane Library ◽

Control Group ◽

Controlled Trials ◽

High Dose ◽

Myopia Progression ◽

Statistical Heterogeneity ◽

Randomised Controlled

Objectives. To explore the rebound effects and safety of atropine on accommodation amplitude in slowing myopia progression. Methods. We conducted a meta-analysis to testify proper dosage of atropine in children with myopia. We searched in PubMed, EMBASE, Ovid, and the Cochrane Library up to March 30, 2021. We selected randomised controlled trials (RCTs) that evaluated the efficacy of atropine for controlling myopia progression in children. We performed the inverse variance random-effects model to pool the data using mean difference (MD) for continuous variables. Statistical heterogeneity was assessed using the I2 test. Additionally, we conducted subgroup analyses and sensitivity analyses. Results. Seventeen RCTs involving 2955 participants were included. Myopia progression was significantly less in the atropine group than that of the control group, with MD = 0.38 D per year (95% confidence interval, 0.20 to 0.56). Less axial elongation was shown with MD = −0.19 mm per year (95% CI, −0.25 to −0.12). There was a statistically difference among various doses ( p = 0.00001 ). In addition, 1.0% atropine showed the rebound effect with MD = −0.54 D per year (95% CI, −0.81 to −0.26) and was more effective in the latter six months than in the former one. Less accommodation amplitude was shown in 0.01% atropine. Conclusion. The efficacy of atropine is dose dependent, and 0.01% atropine may be the optimal dose in slowing myopia progression in children with no accommodation dysfunction. A rebound effect is more prominent in high-dose atropine in the former cessation after discontinuation.

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Efficacy and Safety of Isotonic and Hypotonic Intravenous Maintenance Fluids in Hospitalised Children: A Systematic Review and Meta-Analysis of Randomised Controlled Trials

Children ◽

10.3390/children8090785 ◽

2021 ◽

Vol 8 (9) ◽

pp. 785

Author(s):

Norfarahin Hasim ◽

Mimi Azliha Abu Bakar ◽

Md Asiful Islam

Keyword(s):

Randomised Controlled Trials ◽

Meta Analysis ◽

Adverse Outcomes ◽

Cochrane Library ◽

Controlled Trials ◽

Hypotonic Solution ◽

Medical Patients ◽

Efficacy And Safety ◽

Significant Difference ◽

Randomised Controlled

Hyponatraemia is a known complication in hospitalised children receiving maintenance intravenous fluid. Several studies have been published to investigate the efficacy and safety of intravenous fluids in children. However, there is still an ongoing debate regarding the ideal solution to be used in the paediatric population. Therefore, the aim of this meta-analysis was to investigate the safety and efficacy of administering isotonic versus hypotonic intravenous maintenance fluid in hospitalised children. An extensive search was undertaken on PubMed, Web of Science, Scopus, ScienceDirect, Google Scholar and Cochrane Library on 28 December 2020. Only randomised controlled trials (RCTs) were included. We used the random-effects model for all analyses. Risk ratio (RR) and mean difference with 95% confidence intervals (CIs) were used for dichotomous and continuous outcomes, respectively. The quality of each study was assessed using the Joanna Briggs Institute critical appraisal tool for RCTs. This study is registered with PROSPERO (CRD42021229067). Twenty-two RCTs with a total of 3795 participants were included. The studies encompassed surgical and medical patients admitted to intensive care unit as well as to general wards. We found that hypotonic fluid significantly increases the risk of hyponatremia at both ≤24 h (RR 0.34; 95% CI: 0.26–0.43, p < 0.00001) and >24 h (RR 0.48; 95% CI: 0.36–0.64, p < 0.00001). Isotonic fluid increases the risk of hypernatraemia at ≤24 h (RR 2.15; 95% CI: 1.24–3.73, p = 0.006). The prevalence of hyponatraemia was also higher in the hypotonic group at both ≤24 h (5.7% vs. 23.3%) and >24 h (6.0% vs. 26.3%). There was no statistically significant difference in the risk of developing adverse outcomes between the two groups. Mean serum and urine sodium as well as serum osmolality/osmolarity was lower in the hypotonic group. Isotonic solution is protective against the development of hyponatraemia while hypotonic solution increases the risk of hyponatraemia.

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

BJPsych Open ◽

10.1192/bjo.2021.1003 ◽

2021 ◽

Vol 7 (6) ◽

Author(s):

Shoumitro Deb ◽

Meera Roy ◽

Rachel Lee ◽

Madiha Majid ◽

Bharati Limbu ◽

...

Keyword(s):

Systematic Review ◽

Autism Spectrum Disorder ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Autism Spectrum ◽

Spectrum Disorder ◽

Current Evidence ◽

Cochrane Library ◽

Controlled Trials ◽

Randomised Controlled

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.

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Comparative efficacy and safety of different regimens of ranibizumab for neovascular age-related macular degeneration: a network meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2020-040906 ◽

2021 ◽

Vol 11 (2) ◽

pp. e040906

Author(s):

Xinyu Zhao ◽

Lihui Meng ◽

Youxin Chen

Keyword(s):

Adverse Events ◽

Macular Degeneration ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Age Related Macular Degeneration ◽

Controlled Trials ◽

Cochrane Central Register ◽

Efficacy And Safety ◽

Age Related ◽

Randomised Controlled

ObjectiveTo give a comprehensive efficacy and safety ranking of different therapeutic regimens of ranibizumab for neovascular age-related macular degeneration (nAMD).DesignA systematic review and network meta-analysis.MethodsThe PubMed, Embase, Cochrane Central Register of Controlled Trials, and other clinical trial registries were searched up to 1 October 2019 to identify related randomised controlled trials (RCT) of different regimens of ranibizumab for nAMD. The primary efficacy outcome was the changes of best-corrected visual acuity (BCVA) at 1 year, the primary safety outcome was the incidence of severe ocular adverse events. Secondary outcomes such as changes of central retinal thickness (CRT) were evaluated. We estimated the standardised mean difference (SMD), ORs, 95% CIs, the surface under the cumulative ranking curves and the mean ranks for each outcome using network meta-analyses with random effects by Stata 14.0.ResultsWe identified 26 RCTs involving 10 821 patients with nAMD randomly assigned to 21 different therapeutic regimens of ranibizumab or sham treatment. Ranibizumab 0.5 mg (treat and extend, T&E) is most effective in terms of changes of BCVA (letters, SMD=21.41, 95% CI 19.86 to 22.95) and three or more lines of BCVA improvement (OR=2.83, 95% CI 1.27 to 4.38). However, it could not significantly reduce retreatment times compared with monthly injection (SMD=−0.94, 95% CI −2.26 to 0.39). Ranibizumab 0.5 mg (3+pro re nata)+non-steroidal anti-inflammatory drugs (NSAIDs) is most effective in reducing CRT and port delivery system of ranibizumab (100 mg/mL) could reduce the number of retreatment most significantly. All regimes have no more risk of severe ocular complications (including vitreous haemorrhage, rhegmatogenous retinal detachment, endophthalmitis, retinal tear and retinal pigment epithelium tear) or cardiocerebral vascular complications.ConclusionsRanibizumab 0.5 mg (T&E) is most effective in improving the visual outcome. The administration of topical NSAIDs could achieve additional efficacy in CRT reduction and visual improvement. Both interventions had acceptable risks of adverse events.

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Comparative efficacy and safety of interventions for treating head lice: a protocol for systematic review and network meta-analysis

BMJ Paediatrics Open ◽

10.1136/bmjpo-2021-001129 ◽

2021 ◽

Vol 5 (1) ◽

pp. e001129

Author(s):

Bill Stevenson ◽

Wubshet Tesfaye ◽

Julia Christenson ◽

Cynthia Mathew ◽

Solomon Abrha ◽

...

Keyword(s):

Systematic Review ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Grey Literature ◽

Risk Of Bias ◽

Controlled Trials ◽

Head Lice ◽

Efficacy And Safety ◽

Randomised Controlled ◽

Meta Analyses

BackgroundHead lice infestation is a major public health problem around the globe. Its treatment is challenging due to product failures resulting from rapidly emerging resistance to existing treatments, incorrect treatment applications and misdiagnosis. Various head lice treatments with different mechanism of action have been developed and explored over the years, with limited report on systematic assessments of their efficacy and safety. This work aims to present a robust evidence summarising the interventions used in head lice.MethodThis is a systematic review and network meta-analysis which will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement for network meta-analyses. Selected databases, including PubMed, Embase, MEDLINE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials will be systematically searched for randomised controlled trials exploring head lice treatments. Searches will be limited to trials published in English from database inception till 2021. Grey literature will be identified through Open Grey, AHRQ, Grey Literature Report, Grey Matters, ClinicalTrials.gov, WHO International Clinical Trials Registry and International Standard Randomised Controlled Trials Number registry. Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two independent reviewers, with disagreements resolved via a third reviewer. The primary outcome measure is the relative risk of cure at 7 and 14 days postinitial treatment. Secondary outcome measures may include adverse drug events, ovicidal activity, treatment compliance and acceptability, and reinfestation. Information from direct and indirect evidence will be used to generate the effect sizes (relative risk) to compare the efficacy and safety of individual head lice treatments against a common comparator (placebo and/or permethrin). Risk of bias assessment will be undertaken by two independent reviewers using the Cochrane Risk of Bias tool and the certainty of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations guideline for network meta-analysis. All quantitative analyses will be conducted using STATA V.16.DiscussionThe evidence generated from this systematic review and meta-analysis is intended for use in evidence-driven treatment of head lice infestations and will be instrumental in informing health professionals, public health practitioners and policy-makers.PROSPERO registration numberCRD42017073375.

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