scholarly journals Acupuncture in sham device controlled trials may not be as effective as acupuncture in the real world: a preliminary network meta-analysis of studies of acupuncture for hot flashes in menopausal women

2019 ◽  
Vol 38 (1) ◽  
pp. 37-44 ◽  
Author(s):  
Tae-Hun Kim ◽  
Myeong Soo Lee ◽  
Terje Alraek ◽  
Stephen Birch

Background: Randomised controlled trials of acupuncture performed using sham interventions to control for the placebo effect have mostly used two types of sham techniques: techniques with minimal insertion of acupuncture needles with no additional stimulation (shallow needling control) and techniques with sham acupuncture devices that do not penetrate the skin (sham device control). To achieve successful blinding, sham device controlled acupuncture trials also use the acupuncture base unit in the verum acupuncture group, but in the shallow needling control trials this is not necessary for the verum acupuncture treatment. Objective: In this study, we analysed the estimated comparative effectiveness of these two verum acupuncture modalities in studies of acupuncture for menopausal hot flashes that used two types of sham control treatments. Methods: We conducted a network meta-analysis that included randomised controlled trials of acupuncture for hot flashes. Electronic databases, including Medline, Embase, Cochrane Library and AMED, were searched through March 2017. Data were extracted using a predefined data extraction tool by two independent reviewers. The risk of bias was assessed using the Cochrane risk of bias tool for randomised controlled trials. A five-node network meta-analysis was conducted based on the frequentist framework. Results: Eight studies were included in this review. From the network meta-analysis, we found that verum acupuncture in the shallow needling controlled trials was more effective than verum acupuncture in the sham device controlled trials (SMD −7.27, 95% CI−9.11 to −5.43). Significant heterogeneity and inconsistency were not observed among the included studies or the comparisons. Conclusions: From this preliminary analysis, we found that different types of verum acupuncture may have different effect sizes with respect to the severity of menopausal hot flashes.

2019 ◽  
Vol 123 (8) ◽  
pp. 870-880 ◽  
Author(s):  
Linghan Kuang ◽  
Yongmei Jiang

AbstractProbiotics are being used increasingly in pregnant women, whereas the efficiency on pregnancy outcomes is yet lacking. PubMed, Embase and the Cochrane Library were searched. Relative risks (RR) or weighted mean differences (WMD) with 95 % CI were employed to calculate the summary outcomes. A total of eighteen randomised controlled trials (RCT) including 4356 pregnant women were eligible. The summary RR indicated that probiotic supplementation was associated with a significant decrease in the risk of atopic eczema (RR 0·68; 95 % CI 0·58, 0·81; P < 0·001) and eczema (RR 0·79; 95 % CI 0·68, 0·91; P = 0·002) without significant heterogeneity. Probiotic supplementation was associated with a prolonged gestational age (WMD 0·09; 95 % CI 0·04, 0·15; P = 0·001) with insignificant heterogeneity, whereas no significant effect was exerted on birth weight (P = 0·851). The risks of death (RR 0·34; 95 % CI 0·13, 0·91; P = 0·031) and necrotising enterocolitis (NEC) (RR 0·38; 95 % CI 0·18, 0·81; P = 0·012) were significantly reduced in pregnant women receiving probiotics without evidence of heterogeneity. These findings suggested that probiotics in pregnant women were beneficial for atopic eczema, eczema, gestational age, death and NEC.


2021 ◽  
Author(s):  
Bélène Podmore ◽  
Nawab Qizilbash ◽  
Alessandra Lacetera ◽  
Itziar Ubillos ◽  
Kirsty Andresen ◽  
...  

Objective: To summarise and compare evidence from randomised controlled trials and observational studies of the effect of tocilizumab on in-hospital mortality in patients with covid-19. Design: Systematic review and meta-analysis. Data sources: Searches conducted in Embase and PubMed from July 2020 until 1 March 2021. Study Selection: Observational studies and randomised controlled trials (RCTs) assessing in-hospital mortality in patients receiving tocilizumab compared with standard care or placebo. Data extraction: The primary outcome was in-hospital mortality at 30 days. The risk of bias in observational studies was assessed using the ROBINS-I tool. A fixed effect meta-analysis was used to combine relative risks, with random effects and risk of bias as a sensitivity analysis. Results: Of 5,792 publications screened for inclusion, eight RCTs and 35 observational studies were identified. The RCTs showed an overall relative risk reduction in in-hospital mortality at 30 days of 0.86 (95% CI 0.78 to 0.96) with no statistically significant heterogeneity. 23 of the observational studies had a severe risk of bias, 10 of which did not adjust for potential confounders. The 10 observational studies with moderate risk of bias reported a larger reduction in mortality at 30-days (relative risk 0.72, 95% CI 0.64 to 0.81) but with significant heterogeneity (P<0.01). Conclusion: This meta-analysis provides strong evidence from RCTs that tocilizumab reduces the risk of mortality in hospitalised covid-19 patients. Observational studies with moderate risk of bias exaggerated the benefits on mortality two-fold and showed heterogeneity. Collectively observational studies provide a less reliable evidence base for evaluating treatments for covid-19.


BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e051136
Author(s):  
Jialu Qian ◽  
Shiwen Sun ◽  
Lu Liu ◽  
Xiaoyan Yu

IntroductionPostpartum fatigue is a common symptom among new mothers after their pregnancy. It has a considerable negative impact on women’s functional and mental status as well as the development of babies. Identifying effective interventions to prevent or reduce postpartum fatigue is meaningful to improve the quality of life and avoid adverse outcomes of this vulnerable population. This systematic review aims to synthesise non-pharmacological evidence and evaluate the effectiveness of interventions for reducing postpartum fatigue among puerperas.Methods and analysisThis review will be conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. We will systematically search the Cochrane Library, PubMed, Embase, Web of Science, PsycINFO, CINAHL and ProQuest databases to identify clinical trials implementing non-pharmacological interventions conducted during 0–78 weeks postpartum for fatigue reduction. An additional search of OpenGrey will be conducted to identify grey literature. The search will be performed on 30 March 2021 without restrictions on time and language. Two independent reviewers will be responsible for study selection, data extraction and study quality assessment. The Cochrane risk-of-bias tool will be adopted to evaluate the risk biases of the included randomised controlled trials, and the Risk of Bias in Non-randomised Studies of Interventions will be applied to evaluate non-randomised controlled trials. Any disagreements will be referred to a third reviewer to reach a consensus. Findings will be qualitatively synthesised, and a meta-analysis will be conducted for the statistical combination if outcome data are sufficient and available.Ethics and disseminationThis systematic review will not involve the collection of primary data and will be based on published data. Therefore, ethics approval is not required. The final findings will be disseminated through peer-reviewed journals and academic conferences.PROSPERO registration numberCRD42021234869


2020 ◽  
Vol 97 (1143) ◽  
pp. 40-47
Author(s):  
LiPei Shu ◽  
Jiao Huang ◽  
Jing Chen Liu

Ultrasound guidance has been reported to facilitate the performance of lumbar punctures (LPs). However, the use of ultrasound guidance has not yet received consistent conclusions. We performed a systematic review and meta-analysis to determine the efficacy of ultrasound-guided LPs. PubMed, Embase and the Cochrane Library were searched for randomised controlled trials comparing ultrasound guidance with traditional palpation for LPs in adults. The primary outcome was risk of failed procedures. A random-effects Mantel-Haenzsel model or random-effects inverse variance model was used to calculate relative risks (RRs) or standardised mean differences (SMDs) with 95% CIs. Twenty-eight trials (N=2813) met the inclusion criteria. Ultrasound-guided LPs were associated with a reduced risk of failed procedures (RR=0.58, 95% CI 0.39 to 0.85, p=0.005). No significant heterogeneity was detected (I2=27%) among these trials. It further decreased first attempt to failure (RR=0.43, 95% CI 0.30 to 0.62, p<0.00001), mean attempts to success (SMD=−0.61, 95% CI −0.80 to −0.43, p=0.00001) and incidences of complications of headache and backache (RR=0.63, 95% CI 0.46 to 0.85, p=0.003). Ultrasound guidance is an effective technique for LPs in adults.


2021 ◽  
pp. 146531252110560
Author(s):  
Nidhi P Parmar ◽  
Gabrielle L Thompson ◽  
Nikki E Atack ◽  
Anthony J Ireland ◽  
Martyn Sherriff ◽  
...  

Background: Decalcification and gingivitis caused by plaque accumulation around brackets are common iatrogenic effects of fixed appliances. The influence of conventional versus self-ligating bracket design on microbial colonisation is unknown. Objective: To assess the levels of microbial colonisation associated with conventional and self-ligating brackets. Search sources: Three databases were searched for publications from 2009 to 2021. Data selection: Randomised controlled trials comparing levels of microbial colonisation before and during treatment with conventional and self-ligating brackets were assessed independently and in duplicate. Data extraction: Data were extracted independently by two authors from the studies that fulfilled the inclusion criteria. Risk of bias assessments were made using the revised Cochrane risk of bias tool for randomized trials. The quality of the included studies was assessed using the Critical Appraisal Skills Programme Checklist. Results: A total of 11 randomised controlled trials were included in this systematic review. Six of the studies were found to be at low risk of bias and five presented with some concerns. The studies were considered moderate to high quality. Five trials reported no statistically significant difference in microbial colonisation between bracket types. The remaining studies showed mixed results, with some reporting increased colonisation of conventional brackets and others increased colonisation of self-ligating brackets. The heterogeneity of study methods and outcomes precluded meta-analysis. Conclusion: Of the 11 studies included in this systematic review, five found no differences in colonisation between conventional and self-ligating brackets. The remaining studies showed mixed results. The evidence is inconclusive regarding the association between bracket design and levels of microbial colonisation.


2021 ◽  
Vol 5 (1) ◽  
pp. e001129
Author(s):  
Bill Stevenson ◽  
Wubshet Tesfaye ◽  
Julia Christenson ◽  
Cynthia Mathew ◽  
Solomon Abrha ◽  
...  

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.


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.


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.


2021 ◽  
pp. 1-13
Author(s):  
Davide Papola ◽  
Giovanni Ostuzzi ◽  
Federico Tedeschi ◽  
Chiara Gastaldon ◽  
Marianna Purgato ◽  
...  

Background Psychotherapies are the treatment of choice for panic disorder, but which should be considered as first-line treatment is yet to be substantiated by evidence. Aims To examine the most effective and accepted psychotherapy for the acute phase of panic disorder with or without agoraphobia via a network meta-analysis. Method We conducted a systematic review and network meta-analysis of randomised controlled trials (RCTs) to examine the most effective and accepted psychotherapy for the acute phase of panic disorder. We searched MEDLINE, Embase, PsycInfo and CENTRAL, from inception to 1 Jan 2021 for RCTs. Cochrane and PRISMA guidelines were used. Pairwise and network meta-analyses were conducted using a random-effects model. Confidence in the evidence was assessed using Confidence in Network Meta-Analysis (CINeMA). The protocol was published in a peer-reviewed journal and in PROSPERO (CRD42020206258). Results We included 136 RCTs in the systematic review. Taking into consideration efficacy (7352 participants), acceptability (6862 participants) and the CINeMA confidence in evidence appraisal, the best interventions in comparison with treatment as usual (TAU) were cognitive–behavioural therapy (CBT) (for efficacy: standardised mean differences s.m.d. = −0.67, 95% CI −0.95 to −0.39; CINeMA: moderate; for acceptability: relative risk RR = 1.21, 95% CI −0.94 to 1.56; CINeMA: moderate) and short-term psychodynamic therapy (for efficacy: s.m.d. = −0.61, 95% CI −1.15 to −0.07; CINeMA: low; for acceptability: RR = 0.92, 95% CI 0.54–1.54; CINeMA: moderate). After removing RCTs at high risk of bias only CBT remained more efficacious than TAU. Conclusions CBT and short-term psychodynamic therapy are reasonable first-line choices. Studies with high risk of bias tend to inflate the overall efficacy of treatments. Results from this systematic review and network meta-analysis should inform clinicians and guidelines.


Author(s):  
Omorogieva Ojo ◽  
Sharon M. Weldon ◽  
Trevor Thompson ◽  
Elisabeth J. Vargo

Vitamin D deficiency is highly prevalent amongst pregnant women and is linked to a range of adverse complications, including gestational diabetes. However, there is no consensus among researchers regarding the impact of vitamin D supplementation in alleviating adverse effects in gestational diabetes. The objective of this systematic review and meta-analysis was to determine whether supplementation of vitamin D given to women with gestational diabetes can promote glycaemic control. EMBASE and PubMed were searched up to November, 2018. The selection criteria included randomised controlled trials of the effect of vitamin D supplementation (1000–4762 IU/day) on pregnant women with gestational diabetes mellitus. Study data and outcome measures (fasting blood glucose, glycated haemoglobin and serum insulin) were extracted from included studies. Random-effects models were used for meta-analyses. Heterogeneity tests, and analysis of the risk of bias were conducted. Most of the studies were graded as having either low risk or moderate risk of bias although two studies had a high risk of bias in the areas of blinding of participants and personnel, and incomplete outcome data. On the other hand, the heterogeneity statistic (I2) ranged from 0–41% in the studies included. Five randomised controlled trials were selected for this review and meta-analysis (involving a total of 173 participants supplemented with vitamin D and 153 participants as control drawn from the studies). Vitamin D supplementation was associated with a decrease in fasting blood glucose by a mean of 0.46 mmol/L (−0.68, −0.25) (p < 0.001), glycated haemoglobin by a mean of 0.37% (−0.65, −0.08) (p < 0.01) and serum insulin concentration by mean of 4.10 µIU/mL (−5.50, −2.71) (p < 0.001) compared to controls. This review shows evidence that vitamin D supplementation has the potential to promote glycaemic control in women with Gestational Diabetes Mellitus (GDM). However, due to the limited number of studies in the meta-analysis, the conclusion should be interpreted with caution. Further studies are needed to fully understand the exact mechanism by which vitamin D influences glucose metabolism.


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