scholarly journals Parathyroid hormone analogues for fracture healing: protocol for a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019291 ◽  
Author(s):  
Shenghan Lou ◽  
Houchen Lv ◽  
Zhirui Li ◽  
Peifu Tang ◽  
Yansong Wang

IntroductionFracture healing is a complex physiological process. Impaired healing will increase the need for care and cause serious complications. Thus, identifying strategies to accelerate the rate of healing, preventing delayed unions and non-unions, is essential. Parathyroid hormone (PTH) is a key systemic regulator of calcium and phosphate metabolism. It has been determined that intermittent administration of PTH and its analogue can exert anabolic effect on bone, increase bone mass and reduce bone loss, leading to an increase in bone formation. Owing to their anabolic effect, there is an increasing interest in its potential in promoting the process of fracture healing. However, in clinical studies, the results are in conflict. This objective of this study is to determine the role of PTH analogues for fracture healing in adults.Methods and analysisMEDLINE, EMBASE and Cochrane databases will be searched to identify all randomised controlled trials (RCTs) and quasi-RCTs that compare the different effects between PTH analogues and any other treatments in adults with any type of fracture. The primary outcome is the functional recovery. And the secondary outcomes are fracture union and adverse events. The meta-analysis will be performed using a random effects model. Heterogeneity will be assessed by the P values and I² statistic. And subgroup analyses and sensitivity analyses will be used to explore the heterogeneity. Risk of bias will be assessed using the Cochrane tool and the quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationEthical approval is not required because this proposed systematic review and meta-analysis is based on published data, without including confidential personal data or data on interventions on patients. The findings of this study will be published in a peer-reviewed journaland presented at a relevant conference.PROSPERO registration numberCRD42017062093.

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e026002 ◽  
Author(s):  
Teruhiko Terasawa ◽  
Chisato Hamashima ◽  
Katsuaki Kato ◽  
Isao Miyashiro ◽  
Takaki Yoshikawa ◽  
...  

ObjectivesRecent meta-analyses of eradication therapy inHelicobacter pylori-infected adults reported significant reductions in gastric carcinoma risk. However, concerns about supporting unfocused screening and eradication programme in healthy, asymptomatic populations have arisen. We performed a systematic review and Bayesian meta-analysis to provide an accurate interpretation of randomised evidence on the preventive effectiveness of eradication therapy on gastric carcinoma risk.MethodsWe searched databases including PubMed, Cochrane Central and Embase for reference and citation tracking without language restrictions, from inception through 31 July 2018. Paired investigators independently selected randomised controlled trials (RCTs) comparing eradication therapy with placebo or no treatment for asymptomatic or dyspepticH. pylori-infected adults with no previous gastric carcinoma. The main outcome was gastric carcinoma incidence; secondary outcomes included gastric carcinoma-specific, non-gastric carcinoma and all-cause mortality.ResultsA total of 5 population-based and 2 outpatient care-based RCTs involving 7303 adults were eligible. Eradication algorithms were heterogeneous, and unsuccessful eradication and reinfection were frequently observed. A Bayesian meta-analysis with competing risk outcomes found low-certainty evidence that eradication therapy might be more likely than control to reduce gastric carcinoma risk (HR=0.65; 95% credible interval (CrI) 0.41 to 1.0;I2=11%). The CrIs included the null effects across the subgroup and sensitivity analyses, apart from those based on particular models that excluded two RCTs that enrolled subjects with specific histological findings only (HR=0.55; CrI 0.30 to 0.89;I2=14%). The uncertainty of the average 41% risk reduction in gastric carcinoma-specific mortality included a clinically important mortality risk increase (HR=0.59 favouring eradication therapy; CrI 0.25 to 1.20;I2=13%; low certainty).ConclusionsThere is insufficient evidence to support or refute the effectiveness of eradication therapy in preventing gastric carcinoma inH. pylori-infected, high-risk populations. Rigorously conducted large RCTs of healthy infected adults only would provide evidence of the true efficacy of successful eradication.PROSPERO registration number:CRD42014009245.


BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036020
Author(s):  
Shuhei Murao ◽  
Hidekazu Nakata ◽  
Kazuma Yamakawa

IntroductionTranexamic acid (TXA) is a synthetic derivative of the amino acid lysine that inhibits fibrinolysis by blocking lysine-binding sites on plasminogen, which contribute to reduced bleeding, the need for transfusion and mortality. Although there is reliable evidence of the efficacy of TXA, its effects on other important outcomes, adverse events, including thrombotic events and seizure, remain uncertain.Methods and analysisWe will conduct a systematic review and meta-analysis of randomised controlled trials with the objective of evaluating the incidence of thrombotic adverse events and seizure and how the effect of TXA varies by dose and underlying disease. We will include patients with bleeding in any underlying disease. We will search MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials for randomised controlled trials. The planned date of our systematic search is 1 June 2020. We will follow the recommendations of the Cochrane Collaboration and the Preferred Reporting Items for Systematic Review and Meta-Analysis statement. Subgroup and sensitivity analyses will be performed to explore residual heterogeneity and inconsistency. Meta-regression analysis will be carried out to investigate the association between the incidence of adverse events and the TXA dose. The risk of systematic errors (bias) and random errors will be assessed and the overall quality of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationThis study will not involve primary data collection, and formal ethics approval will therefore not be required. We aim to publish this systematic review in a peer-review journal.Trial registration numberUMIN000039611.


2015 ◽  
Vol 114 (9) ◽  
pp. 1360-1374 ◽  
Author(s):  
Nazanin Moslehi ◽  
Sakineh Shab-Bidar ◽  
Parvin Mirmiran ◽  
Farhad Hosseinpanah ◽  
Fereidoun Azizi

AbstractThis systematic review aimed to assess the determinants of the parathyroid hormone (PTH) level response to vitamin D supplementation. We searched Medline, Google Scholar and the reference lists of previous reviews. All randomised controlled trials (RCT) on vitamin D supplementation that involved apparently healthy human subjects with a report of PTH were selected. Potential studies were screened independently and in duplicate. Results are summarised as mean differences with 95 % confidence intervals. Quality assessment, subgroup analysis, meta-analysis and meta-regression analysis were carried out. Thirty-three vitamin D supplementation RCT were included. Vitamin D supplementation significantly raised circulating 25-hydroxyvitamin D (25(OH)D) with significant heterogeneity among studies with a pooled mean difference (PMD) of 15.5 ng/ml (test for heterogeneity: P<0·001 and I2=97·3 %). Vitamin D supplementation significantly reduced PTH level with PMD of −8·0 pg/ml, with significant heterogeneity ((test for heterogeneity: P<0·001) and the I2 value was 97·3 %). In the subgroup analyses, the optimum treatment effect for PTH was observed with Ca doses of 600–1200 mg/d (−22·48 pg/ml), after the duration of a >12-month trial (−18·36 pg/ml), with low baseline 25(OH)D concentration of <20 ng/ml (−16·70 pg/ml) and in those who were overweight and obese (−18·11 pg/ml). Despite the present meta-analysis being hindered by some limitations, it provided some interesting evidence, suggesting that suppression of PTH level needs higher vitamin D intake (75 μg/d) than the current recommendations and longer durations (12 months), which should be taken into account for nutritional recommendations.


2012 ◽  
Vol 201 (3) ◽  
pp. 180-185 ◽  
Author(s):  
Christopher Bridle ◽  
Kathleen Spanjers ◽  
Shilpa Patel ◽  
Nicola M. Atherton ◽  
Sarah E. Lamb

BackgroundThe prevelance of depression in older people is high, treatment is inadequate, it creates a substantial burden and is a public health priority for which exercise has been proposed as a therapeutic strategy.AimsTo estimate the effect of exercise on depressive symptoms among older people, and assess whether treatment effect varies depending on the depression criteria used to determine participant eligibility.MethodSystematic review and meta-analysis of randomised controlled trials of exercise for depression in older people.ResultsNine trials met the inclusion criteria and seven were meta-analysed. Exercise was associated with significantly lower depression severity (standardised mean difference (SMD) =–0.34, 95% CI –0.52 to –0.17), irrespective of whether participant eligibility was determined by clinical diagnosis (SMD =–0.38, 95% CI –0.67 to –0.10) or symptom checklist (SMD =–0.34, 95% CI –0.62 to –0.06). Results remained significant in sensitivity analyses.ConclusionsOur findings suggest that, for older people who present with clinically meaningful symptoms of depression, prescribing structured exercise tailored to individual ability will reduce depression severity.


BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e016863 ◽  
Author(s):  
Elizabeth P Neale ◽  
Linda C Tapsell ◽  
Vivienne Guan ◽  
Marijka J Batterham

ObjectivesTo examine the effect of nut consumption on inflammatory biomarkers and endothelial function.DesignA systematic review and meta-analysis.Data sourcesMEDLINE, PubMed, Cumulative Index to Nursing and Allied Health Literature and Cochrane Central Register of Controlled Trials (all years to 13 January 2017).Eligibility criteriaRandomised controlled trials (with a duration of 3 weeks or more) or prospective cohort designs conducted in adults; studies assessing the effect of consumption of tree nuts or peanuts on C-reactive protein (CRP), adiponectin, tumour necrosis factor alpha, interleukin-6, intercellular adhesion molecule 1, vascular cell adhesion protein 1 and flow-mediated dilation (FMD).Data extraction and analysisRelevant data were extracted for summary tables and analyses by two independent researchers. Random effects meta-analyses were conducted to explore weighted mean differences (WMD) in change or final mean values for each outcome.ResultsA total of 32 studies (all randomised controlled trials) were included in the review. The effect of nut consumption on FMD was explored in nine strata from eight studies (involving 652 participants), with consumption of nuts resulting in significant improvements in FMD (WMD: 0.79%(95% CI 0.35 to 1.23)). Nut consumption resulted in small, non-significant differences in CRP (WMD: −0.01 mg/L (95% CI −0.06 to 0.03)) (26 strata from 25 studies), although sensitivity analyses suggest results for CRP may have been influenced by two individual studies. Small, non-significant differences were also found for other biomarkers of inflammation.ConclusionsThis systematic review and meta-analysis of the effects of nut consumption on inflammation and endothelial function found evidence for favourable effects on FMD, a measure of endothelial function. Non-significant changes in other biomarkers indicate a lack of consistent evidence for effects of nut consumption on inflammation. The findings of this analysis suggest a need for more research in this area, with a particular focus on randomised controlled trials.PROSPERO registration numberCRD42016045424.


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


2002 ◽  
Vol 20 (4) ◽  
pp. 846-852 ◽  
Author(s):  
J. Martin ◽  
A.N.A. Donaldson ◽  
R. Villarroel ◽  
M.K.B. Parmar ◽  
E. Ernst ◽  
...  

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