Pub Date : 2025-12-03DOI: 10.1002/14651858.CD001059.pub6
Catherine A Cluver, Christa Rohwer, Anke C Rohwer
<p><strong>Rationale: </strong>Calcium supplementation may reduce the risk of developing pre-eclampsia, a common cause of serious maternal and neonatal morbidity and death. However, its effectiveness in preventing hypertensive disorders of pregnancy is uncertain. This updates a review last published in 2018.</p><p><strong>Objectives: </strong>To assess the effects of calcium supplementation during pregnancy on hypertensive disorders of pregnancy and related maternal and child outcomes.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, four other databases and two trials registries to 7 January 2025, and screened reference lists of retrieved studies and relevant systematic reviews.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) that compared calcium supplementation during pregnancy with placebo or standard care only. We compared low and high doses. Trials conducted after 2010 had to be prospectively registered. We assessed trustworthiness.</p><p><strong>Outcomes: </strong>Critical outcomes were pre-eclampsia for women and perinatal loss for children. Important outcomes for women included maternal death, maternal death or severe morbidity, adverse effects and preterm delivery before 37 weeks. Important outcomes for children were neonatal death or severe morbidity, stillbirth, and neonatal death.</p><p><strong>Risk of bias: </strong>We assessed risk of bias in RCTs using version 2 of the Cochrane tool (RoB 2).</p><p><strong>Synthesis methods: </strong>Two review authors independently selected trials, extracted data, and assessed bias and trustworthiness. We pooled data using random-effects meta-analysis. We assessed certainty of evidence using GRADE.</p><p><strong>Included studies: </strong>We included 10 RCTs with 37,504 participants. All trials provided standard care. Eight compared calcium supplementation to placebo, and two compared low- to high-dose calcium supplementation. We excluded 20 previously included trials; 11 because eligibility criteria changed and nine because they are awaiting classification due to trustworthiness issues.</p><p><strong>Synthesis of results: </strong>Calcium supplementation versus placebo Calcium may result in little to no difference in pre-eclampsia (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.67 to 1.04; 6 RCTs, 15,364 women; risk difference (RD) 9/1000 fewer, 95% CI 17 fewer to 2 more; low-certainty evidence). Sensitivity analysis excluding small studies (fewer than 500 participants) indicates little to no difference in pre-eclampsia (RR 0.92, 95% CI 0.79 to 1.05; 4 RCTs, 14,730 women; high-certainty evidence). The evidence is very uncertain about the effect of calcium on maternal death (RR 0.33, 95% CI 0.06 to 1.83; 3 RCTs, 9430 women; very low-certainty evidence) and on adverse effects (RR 2.16, 95% CI 0.43 to 10.78; 2 RCTs, 714 women; very low-certainty evidence). Calcium probably results in little to no difference in the composi
理由:补充钙可以降低发生子痫前期的风险,子痫前期是孕产妇和新生儿严重发病和死亡的常见原因。然而,其预防妊娠期高血压疾病的有效性尚不确定。这是对2018年发表的一篇综述的更新。目的:评估妊娠期补钙对妊娠期高血压疾病及相关母婴结局的影响。检索方法:检索截至2025年1月7日的CENTRAL、MEDLINE、Embase等4个数据库和2个试验注册库,筛选已检索研究的参考文献列表和相关系统评价。入选标准:我们纳入了随机对照试验(RCTs),将孕期补钙与安慰剂或标准护理进行比较。我们比较了低剂量和高剂量。2010年以后进行的试验必须进行前瞻性登记。我们评估了可信度。结局:关键结局为妇女先兆子痫和儿童围产期损失。妇女的重要结局包括产妇死亡、产妇死亡或严重发病率、不良反应和37周前早产。儿童的重要结局是新生儿死亡或严重发病率、死产和新生儿死亡。偏倚风险:我们使用Cochrane工具第2版(RoB 2)评估了rct的偏倚风险。综合方法:两位综述作者独立选择试验,提取数据,评估偏倚和可信度。我们使用随机效应荟萃分析汇总数据。我们使用GRADE评估证据的确定性。纳入研究:纳入10项随机对照试验,共37,504名受试者。所有试验均提供标准护理。8组比较钙补充剂和安慰剂,2组比较低剂量和高剂量钙补充剂。我们排除了20个先前纳入的试验;11个是因为资格标准发生了变化,9个是因为可信度问题而等待分类。结果综合:钙补充剂与安慰剂钙可能导致子痫前期差异很小或没有差异(风险比(RR) 0.83, 95%可信区间(CI) 0.67至1.04;6项随机对照试验,15364名女性;风险差(RD)减少9/1000,95% CI减少17至增加2;确定性的证据)。排除小型研究(少于500名受试者)的敏感性分析表明,先兆子痫的差异很小或没有差异(RR 0.92, 95% CI 0.79至1.05;4项随机对照试验,14,730名女性;高确定性证据)。钙对孕产妇死亡的影响(RR 0.33, 95% CI 0.06 - 1.83; 3项随机对照试验,9430名妇女;极低确定性证据)和不良反应(RR 2.16, 95% CI 0.43 - 10.78; 2项随机对照试验,714名妇女;极低确定性证据)的证据非常不确定。钙可能导致产妇死亡或严重发病率的综合结果几乎没有差异(RR 0.80, 95% CI 54至1.19;1项RCT, 8312名妇女;中等确定性证据),并且可能导致围产期损失几乎没有差异(RR 0.93, 95% CI 0.64至1.35;4项RCT, 6832名妇女;RD减少1/1000,95% CI 6少至6多;低确定性证据)。关于钙对37周前早产的影响,证据非常不确定(RR 0.83, 95% CI 0.65 ~ 1.05; 6项随机对照试验,15,074名妇女;非常低确定性证据)。排除小型研究的敏感性分析显示37周前早产差异不大或无差异(RR 0.97, 95% CI 0.85至1.11;4项随机对照试验,14,429名妇女;高确定性证据)。钙可能导致死产的差异很小或没有差异(RR 0.91, 95% CI 0.72至1.15;4项随机对照试验,14,085名妇女;中等确定性证据),但其对新生儿死亡的影响证据非常不确定(RR 1.09, 95% CI 0.50至2.38;4项随机对照试验,13,300名妇女;非常低确定性证据)。没有试验测量新生儿死亡或严重发病率。低剂量钙与高剂量钙在子痫前期可能几乎没有差异(RR 0.96, 95% CI 0.73 - 1.25; 2项随机对照试验,22,000名女性;低确定性证据)。关于低剂量与高剂量钙对孕产妇死亡的影响的证据非常不确定(RR 1.20, 95% CI 0.36至3.94;2项随机对照试验,22,000名妇女;极低确定性证据)。低剂量钙和高剂量钙在围产期损失(RR 1.02, 95% CI 0.91至1.16;2项随机对照试验,21,412名妇女;高确定性证据)和死产(RR 0.99, 95% CI 0.84至1.16;2项随机对照试验,21,131名妇女;高确定性证据)方面几乎没有差异。低剂量钙和高剂量钙在37周前早产中可能几乎没有差异(RR 0.98, 95% CI 0.81至1.17;2项随机对照试验,20,578名妇女;中等确定性证据)。没有试验测量产妇死亡或严重发病率、不良反应、新生儿死亡或严重发病率或新生儿死亡。 作者的结论:补钙与安慰剂荟萃分析显示,与安慰剂相比,补钙对先兆子痫的影响可能很小或没有差异,但我们非常不确定其对37周前早产的影响。然而,只有大型试验的敏感性分析(主要分析中95%的参与者)的高确定性证据显示,在37周之前的子痫前期和早产方面几乎没有差异。产妇死亡非常罕见,因此有关的证据非常不确定。补充钙可能对产妇死亡或严重发病率的综合结果几乎没有影响,可能对围产期损失几乎没有影响,可能对死产几乎没有影响。关于不良反应和新生儿死亡的证据非常不确定。没有试验测量新生儿死亡或严重发病率。基线钙摄入水平和先兆子痫风险状态对我们的研究结果没有影响。低剂量与高剂量补钙低剂量与高剂量补钙对低钙摄入人群中子痫前期高风险妇女的预后没有差异。低剂量补钙对子痫前期的影响微乎其微。产妇死亡(每10 000名妇女中有5人死亡)很罕见;证据非常不确定。低剂量钙对围产期损失和死产的影响微乎其微,对37周前早产的影响微乎其微。没有试验测量严重的产妇发病率、新生儿死亡、严重的新生儿发病率或不良反应。经费:本综述由世界卫生组织部分资助。注册:更新协议(2024)PROSPERO: CRD42024623889 Review update (2018) DOI: 10.1002/14651858.CD001059。pub5原综述(2002)DOI: 10.002 /14651858. cd001059。
{"title":"Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems.","authors":"Catherine A Cluver, Christa Rohwer, Anke C Rohwer","doi":"10.1002/14651858.CD001059.pub6","DOIUrl":"10.1002/14651858.CD001059.pub6","url":null,"abstract":"<p><strong>Rationale: </strong>Calcium supplementation may reduce the risk of developing pre-eclampsia, a common cause of serious maternal and neonatal morbidity and death. However, its effectiveness in preventing hypertensive disorders of pregnancy is uncertain. This updates a review last published in 2018.</p><p><strong>Objectives: </strong>To assess the effects of calcium supplementation during pregnancy on hypertensive disorders of pregnancy and related maternal and child outcomes.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, four other databases and two trials registries to 7 January 2025, and screened reference lists of retrieved studies and relevant systematic reviews.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) that compared calcium supplementation during pregnancy with placebo or standard care only. We compared low and high doses. Trials conducted after 2010 had to be prospectively registered. We assessed trustworthiness.</p><p><strong>Outcomes: </strong>Critical outcomes were pre-eclampsia for women and perinatal loss for children. Important outcomes for women included maternal death, maternal death or severe morbidity, adverse effects and preterm delivery before 37 weeks. Important outcomes for children were neonatal death or severe morbidity, stillbirth, and neonatal death.</p><p><strong>Risk of bias: </strong>We assessed risk of bias in RCTs using version 2 of the Cochrane tool (RoB 2).</p><p><strong>Synthesis methods: </strong>Two review authors independently selected trials, extracted data, and assessed bias and trustworthiness. We pooled data using random-effects meta-analysis. We assessed certainty of evidence using GRADE.</p><p><strong>Included studies: </strong>We included 10 RCTs with 37,504 participants. All trials provided standard care. Eight compared calcium supplementation to placebo, and two compared low- to high-dose calcium supplementation. We excluded 20 previously included trials; 11 because eligibility criteria changed and nine because they are awaiting classification due to trustworthiness issues.</p><p><strong>Synthesis of results: </strong>Calcium supplementation versus placebo Calcium may result in little to no difference in pre-eclampsia (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.67 to 1.04; 6 RCTs, 15,364 women; risk difference (RD) 9/1000 fewer, 95% CI 17 fewer to 2 more; low-certainty evidence). Sensitivity analysis excluding small studies (fewer than 500 participants) indicates little to no difference in pre-eclampsia (RR 0.92, 95% CI 0.79 to 1.05; 4 RCTs, 14,730 women; high-certainty evidence). The evidence is very uncertain about the effect of calcium on maternal death (RR 0.33, 95% CI 0.06 to 1.83; 3 RCTs, 9430 women; very low-certainty evidence) and on adverse effects (RR 2.16, 95% CI 0.43 to 10.78; 2 RCTs, 714 women; very low-certainty evidence). Calcium probably results in little to no difference in the composi","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD001059"},"PeriodicalIF":8.8,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12672055/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145660508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-02DOI: 10.1002/14651858.CD016158
Eduardo I Leão, Aline Rocha, Ana Carolina Pereira Nunes Pinto, Diego Adão, Humberto Saconato
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: Objective 1: to assess the effects of robotic-assisted thoracoscopic surgery lobectomy versus conventional open lobectomy or video-assisted thoracoscopic surgery lobectomy in people with early-stage non-small cell lung cancer (NSCLC). Objective 2: to appraise full economic evaluations comparing robotic-assisted thoracoscopic surgery with open lobectomy or video-assisted thoracoscopic surgery lobectomy for early-stage NSCLC by extracting data on resource use, costs, utilities, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) from societal and healthcare perspectives.
{"title":"Robotic-assisted thoracoscopic surgery lobectomy versus open or video-assisted thoracoscopic surgery lobectomy for early-stage non-small cell lung cancer.","authors":"Eduardo I Leão, Aline Rocha, Ana Carolina Pereira Nunes Pinto, Diego Adão, Humberto Saconato","doi":"10.1002/14651858.CD016158","DOIUrl":"10.1002/14651858.CD016158","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: Objective 1: to assess the effects of robotic-assisted thoracoscopic surgery lobectomy versus conventional open lobectomy or video-assisted thoracoscopic surgery lobectomy in people with early-stage non-small cell lung cancer (NSCLC). Objective 2: to appraise full economic evaluations comparing robotic-assisted thoracoscopic surgery with open lobectomy or video-assisted thoracoscopic surgery lobectomy for early-stage NSCLC by extracting data on resource use, costs, utilities, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) from societal and healthcare perspectives.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD016158"},"PeriodicalIF":8.8,"publicationDate":"2025-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12670493/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145653803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-28DOI: 10.1002/14651858.CD013705.pub4
Jacqueline Dinnes, Sarah Berhane, Jennifer Walsh, Paul Reidy, Aaron Doherty, Bethany Hillier, Katie Scandrett, Dineshani Hettiarachchi, Fahmida Islam, Yasith Mathangasinghe, Nicholas Nyaaba, Melissa Taylor, Praveen Weeratunga, Dakshitha Wickramasinghe, Susanna S van Wyk, Jane Cunningham, Clare Davenport, Sabine Dittrich, Devy Emperador, Lotty Hooft, Mariska Mg Leeflang, Matthew Df McInnes, René Spijker, Jan Y Verbakel, Yemisi Takwoingi, Sian Taylor-Phillips, Ann Van den Bruel, Jonathan J Deeks
<p><strong>Background: </strong>Accurate rapid diagnostic tests for SARS-CoV-2 infection could help manage the COVID-19 pandemic by potentially increasing access to testing and speed detection of infection, as well as informing clinical and public health management decisions to reduce transmission. Previous iterations of this review provided clear and conclusive evidence of superior test performance in those experiencing possible signs and symptoms of Covid-19. However, test performance in asymptomatic individuals and sensitivity by setting and indication for testing remains unclear. This is the fourth iteration of this review, first published in 2020.</p><p><strong>Objectives: </strong>To assess the diagnostic accuracy of rapid, point-of-care antigen tests (Ag-RDTs) for diagnosis of SARS-CoV-2 infection in asymptomatic population groups.</p><p><strong>Search methods: </strong>We searched the COVID-19 Open Access Project living evidence database from the University of Bern (which includes daily updates from MEDLINE and Embase and preprints from medRxiv and bioRxiv) on 17 February 2022. We included independent evaluations from national reference laboratories, FIND and the Diagnostics Global Health website. We did not apply language restrictions.</p><p><strong>Selection criteria: </strong>We included test accuracy studies of any design that evaluated commercially produced, rapid antigen tests in asymptomatic people tested because of known or suspected contact with SARS-CoV-2 infection, known SARS-CoV-2 infection or known absence of infection, or those who were being screened for infection. We included evaluations of single applications of a test (one test result reported per person). Reference standards for presence or absence of infection were any laboratory-based molecular test (primarily reverse transcription polymerase chain reaction (RT-PCR)).</p><p><strong>Data collection and analysis: </strong>We used standard screening procedures with three reviewers. Two reviewers independently carried out quality assessment (using the QUADAS-2 tool) and extracted study results. Other study characteristics were extracted by one review author and checked by a second. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test, and pooled data using the bivariate model. We investigated heterogeneity by including indicator variables in the random-effects logistic regression models. We tabulated results by test manufacturer and compliance with manufacturer instructions for use and according to symptom status.</p><p><strong>Main results: </strong>We included 146 study cohorts (described in 130 study reports). The main results relate to 164 evaluations of single test applications including 144,250 unique samples (7104 with confirmed SARS-CoV-2) obtained from asymptomatic or mainly asymptomatic populations. Studies were mainly conducted in Europe (85/146, 58%), and evaluated 41 different commercial antigen assays (test kit). Only six
{"title":"Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.","authors":"Jacqueline Dinnes, Sarah Berhane, Jennifer Walsh, Paul Reidy, Aaron Doherty, Bethany Hillier, Katie Scandrett, Dineshani Hettiarachchi, Fahmida Islam, Yasith Mathangasinghe, Nicholas Nyaaba, Melissa Taylor, Praveen Weeratunga, Dakshitha Wickramasinghe, Susanna S van Wyk, Jane Cunningham, Clare Davenport, Sabine Dittrich, Devy Emperador, Lotty Hooft, Mariska Mg Leeflang, Matthew Df McInnes, René Spijker, Jan Y Verbakel, Yemisi Takwoingi, Sian Taylor-Phillips, Ann Van den Bruel, Jonathan J Deeks","doi":"10.1002/14651858.CD013705.pub4","DOIUrl":"10.1002/14651858.CD013705.pub4","url":null,"abstract":"<p><strong>Background: </strong>Accurate rapid diagnostic tests for SARS-CoV-2 infection could help manage the COVID-19 pandemic by potentially increasing access to testing and speed detection of infection, as well as informing clinical and public health management decisions to reduce transmission. Previous iterations of this review provided clear and conclusive evidence of superior test performance in those experiencing possible signs and symptoms of Covid-19. However, test performance in asymptomatic individuals and sensitivity by setting and indication for testing remains unclear. This is the fourth iteration of this review, first published in 2020.</p><p><strong>Objectives: </strong>To assess the diagnostic accuracy of rapid, point-of-care antigen tests (Ag-RDTs) for diagnosis of SARS-CoV-2 infection in asymptomatic population groups.</p><p><strong>Search methods: </strong>We searched the COVID-19 Open Access Project living evidence database from the University of Bern (which includes daily updates from MEDLINE and Embase and preprints from medRxiv and bioRxiv) on 17 February 2022. We included independent evaluations from national reference laboratories, FIND and the Diagnostics Global Health website. We did not apply language restrictions.</p><p><strong>Selection criteria: </strong>We included test accuracy studies of any design that evaluated commercially produced, rapid antigen tests in asymptomatic people tested because of known or suspected contact with SARS-CoV-2 infection, known SARS-CoV-2 infection or known absence of infection, or those who were being screened for infection. We included evaluations of single applications of a test (one test result reported per person). Reference standards for presence or absence of infection were any laboratory-based molecular test (primarily reverse transcription polymerase chain reaction (RT-PCR)).</p><p><strong>Data collection and analysis: </strong>We used standard screening procedures with three reviewers. Two reviewers independently carried out quality assessment (using the QUADAS-2 tool) and extracted study results. Other study characteristics were extracted by one review author and checked by a second. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test, and pooled data using the bivariate model. We investigated heterogeneity by including indicator variables in the random-effects logistic regression models. We tabulated results by test manufacturer and compliance with manufacturer instructions for use and according to symptom status.</p><p><strong>Main results: </strong>We included 146 study cohorts (described in 130 study reports). The main results relate to 164 evaluations of single test applications including 144,250 unique samples (7104 with confirmed SARS-CoV-2) obtained from asymptomatic or mainly asymptomatic populations. Studies were mainly conducted in Europe (85/146, 58%), and evaluated 41 different commercial antigen assays (test kit). Only six ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD013705"},"PeriodicalIF":8.8,"publicationDate":"2025-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12661640/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-28DOI: 10.1002/14651858.CD015173.pub2
Htar Htar Aung, Cho Naing, Han Ni, Saint Nway Aye, Norah Htet Htet, Siang Tong Kew, Chavdar S Pavlov
<p><strong>Rationale: </strong>Liver cirrhosis and its complications increase the risk of death associated with end-stage liver disease. Liver transplantation is an option, but the procedure may have significant morbidity and mortality risks, in addition to the shortage of liver donors. Human stem cell interventions are expected to be able to remodel injured liver tissue and to maintain liver function in people with decompensated cirrhosis. So far, results of randomised clinical trials on the effects of human stem cells in adults with decompensated cirrhosis have been inconsistent.</p><p><strong>Objectives: </strong>To assess the benefits and harms of human stem cell intervention in adults with decompensated cirrhosis, regardless of ethnicity, sex, types of stem cell, route of stem cell injection, and administered dose.</p><p><strong>Search methods: </strong>We searched the Cochrane Hepato-Biliary Group (CHBG) Controlled Trials Register, CENTRAL, MEDLINE, five other databases and four trials registers, in addition to reference checking, citation searching, and contacting study authors to identify the trials for inclusion. Last date of search - 4 October 2024.</p><p><strong>Eligibility criteria: </strong>Randomised clinical trials comparing any stem cell type versus placebo, conventional, or no active treatment for people (≥ 18 years old) with decompensated cirrhosis. We included trials with any route of administration, frequency, and number of stem cells administered in people with decompensated cirrhosis and irrespective of the reported outcomes of interest to our review, language, year, format, and status of publication. We excluded quasi-randomised studies.</p><p><strong>Outcomes: </strong>Our critical outcomes were all-cause mortality, serious adverse events, and quality of life. Our important outcomes were complications, non-serious adverse events, and liver function.</p><p><strong>Risk of bias: </strong>We assessed the risk of bias (RoB) in the outcome results of interest to our review, using the RoB 2 tool.</p><p><strong>Synthesis methods: </strong>We conducted our meta-analyses, including outcome results, irrespective of our risk of bias judgements. Our primary analyses, on which we based our conclusions, included outcome data at the longest follow-up. We presented the results of dichotomous outcomes as risk ratios (RR) and continuous outcomes as mean difference or standardised mean difference (SMD), with 95% confidence intervals (CI). We used the random-effects model for our primary analyses. We used the Restricted Maximum Likelihood (REML) estimator to estimate the differences in the random-effects model with the inverse-variance method, which includes a measure of the degree of heterogeneity in the study weights. We employed the Hartung-Knapp-Sidik-Jonkman (HKSJ) method to compute a CI for the meta-analysis effect estimate in situations with at least three trials and an estimate of heterogeneity greater than zero. In the case of pooled
{"title":"Human stem cells for decompensated cirrhosis in adults.","authors":"Htar Htar Aung, Cho Naing, Han Ni, Saint Nway Aye, Norah Htet Htet, Siang Tong Kew, Chavdar S Pavlov","doi":"10.1002/14651858.CD015173.pub2","DOIUrl":"10.1002/14651858.CD015173.pub2","url":null,"abstract":"<p><strong>Rationale: </strong>Liver cirrhosis and its complications increase the risk of death associated with end-stage liver disease. Liver transplantation is an option, but the procedure may have significant morbidity and mortality risks, in addition to the shortage of liver donors. Human stem cell interventions are expected to be able to remodel injured liver tissue and to maintain liver function in people with decompensated cirrhosis. So far, results of randomised clinical trials on the effects of human stem cells in adults with decompensated cirrhosis have been inconsistent.</p><p><strong>Objectives: </strong>To assess the benefits and harms of human stem cell intervention in adults with decompensated cirrhosis, regardless of ethnicity, sex, types of stem cell, route of stem cell injection, and administered dose.</p><p><strong>Search methods: </strong>We searched the Cochrane Hepato-Biliary Group (CHBG) Controlled Trials Register, CENTRAL, MEDLINE, five other databases and four trials registers, in addition to reference checking, citation searching, and contacting study authors to identify the trials for inclusion. Last date of search - 4 October 2024.</p><p><strong>Eligibility criteria: </strong>Randomised clinical trials comparing any stem cell type versus placebo, conventional, or no active treatment for people (≥ 18 years old) with decompensated cirrhosis. We included trials with any route of administration, frequency, and number of stem cells administered in people with decompensated cirrhosis and irrespective of the reported outcomes of interest to our review, language, year, format, and status of publication. We excluded quasi-randomised studies.</p><p><strong>Outcomes: </strong>Our critical outcomes were all-cause mortality, serious adverse events, and quality of life. Our important outcomes were complications, non-serious adverse events, and liver function.</p><p><strong>Risk of bias: </strong>We assessed the risk of bias (RoB) in the outcome results of interest to our review, using the RoB 2 tool.</p><p><strong>Synthesis methods: </strong>We conducted our meta-analyses, including outcome results, irrespective of our risk of bias judgements. Our primary analyses, on which we based our conclusions, included outcome data at the longest follow-up. We presented the results of dichotomous outcomes as risk ratios (RR) and continuous outcomes as mean difference or standardised mean difference (SMD), with 95% confidence intervals (CI). We used the random-effects model for our primary analyses. We used the Restricted Maximum Likelihood (REML) estimator to estimate the differences in the random-effects model with the inverse-variance method, which includes a measure of the degree of heterogeneity in the study weights. We employed the Hartung-Knapp-Sidik-Jonkman (HKSJ) method to compute a CI for the meta-analysis effect estimate in situations with at least three trials and an estimate of heterogeneity greater than zero. In the case of pooled","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD015173"},"PeriodicalIF":8.8,"publicationDate":"2025-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12661637/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-27DOI: 10.1002/14651858.CD004143.pub6
Magdalena Bofill Rodriguez, Li Ning Yong, Sanja Mirkov, Christine Bekos, Anne Lethaby, Cindy Farquhar
<p><strong>Background: </strong>Hormone therapy is widely provided to control menopausal symptoms and has been used for the management and prevention of cardiovascular disease, osteoporosis and dementia in older women. This is an updated version of a Cochrane review first published in 2005.</p><p><strong>Objectives: </strong>To assess the long-term effects of prolonged use (at least one year) of hormone therapy on mortality, cardiovascular outcomes, cancer, gallbladder disease, fractures and cognition in perimenopausal and postmenopausal women.</p><p><strong>Search methods: </strong>We used the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, three other databases and two trial registers, together with reference checking, citation searching and contact with study authors to identify the studies included in the review. The latest search date was 26 September 2024.</p><p><strong>Selection criteria: </strong>We included randomised, double-blind trials in which peri- or postmenopausal women took hormone therapy or placebo for at least one year. We included various oestrogen formulations, with or without progestogens. We focused on studies assessing hormone therapy's effects on long-term clinical outcomes, including death, coronary events and cancer. Hormone therapy's efficacy in managing menopausal symptoms was beyond the scope of this review, and is assessed in other Cochrane reviews.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies, assessed risk of bias and extracted data. We calculated risk ratios (RRs) for dichotomous data and mean differences (MDs) for continuous data, along with 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE.</p><p><strong>Main results: </strong>We included 24 studies - with two newly added in this update - involving 45,660 participants. We derived nearly 70% of the data from two well-conducted studies: the Heart and Estrogen/progestin Replacement Study (HERS 1998) and the large, multi-component Women's Health Initiative research programme, which included two hormone therapy arms (WHI 1998). Across all the studies, most participants were postmenopausal American women with one or more comorbidities. The mean participant age in most studies was over 60 years. Only one included study focused on perimenopausal women. We present full results for all included studies with available data in the main review. The results presented below are drawn from WHI 1998, in which the combined hormone therapy arm and the oestrogen-only arm were run concurrently, with women assigned to the appropriate trial based on their uterus status. One study with 16,608 postmenopausal women with an intact uterus compared combined continuous hormone therapy (conjugated equine oestrogen and medroxyprogesterone acetate) to placebo, and measured outcomes at an average of 5.6 years of follow-up. Based on this study, combined continuous hormo
背景:激素治疗被广泛用于控制绝经期症状,并已被用于老年妇女心血管疾病、骨质疏松症和痴呆的管理和预防。这是2005年首次发表的Cochrane综述的更新版本。目的:评估长期使用(至少一年)激素治疗对围绝经期和绝经后妇女死亡率、心血管结局、癌症、胆囊疾病、骨折和认知的长期影响。检索方法:我们使用Cochrane妇科与生育组专业注册库、CENTRAL、MEDLINE、其他三个数据库和两个试验注册库,结合参考文献检查、引文检索和与研究作者的联系来确定纳入综述的研究。最近一次搜索日期是2024年9月26日。选择标准:我们纳入了随机、双盲试验,其中围绝经期或绝经后妇女服用激素治疗或安慰剂至少一年。我们包括了各种雌激素配方,有或没有孕激素。我们的研究重点是评估激素治疗对长期临床结果的影响,包括死亡、冠状动脉事件和癌症。激素治疗在控制更年期症状方面的疗效超出了本综述的范围,并且在其他Cochrane综述中进行了评估。数据收集和分析:两位综述作者独立选择研究,评估偏倚风险并提取数据。我们计算了二分类数据的风险比(rr)和连续数据的平均差异(md),以及95%置信区间(ci)。我们使用GRADE评估证据的确定性。主要结果:我们纳入了24项研究,其中两项是在本次更新中新增的,涉及45,660名参与者。我们从两项执行良好的研究中获得了近70%的数据:心脏和雌激素/黄体酮替代研究(HERS 1998)和大型、多成分的妇女健康倡议研究项目,其中包括两个激素治疗组(WHI 1998)。在所有的研究中,大多数参与者是绝经后有一种或多种合并症的美国妇女。在大多数研究中,参与者的平均年龄超过60岁。只有一项纳入的研究关注的是围绝经期妇女。我们在主要综述中提供了所有纳入研究的完整结果。下面的结果来自1998年的WHI,其中联合激素治疗组和仅雌激素治疗组同时进行,妇女根据其子宫状况被分配到适当的试验中。一项对16608名子宫完整的绝经后妇女的研究比较了联合持续激素治疗(结合马雌激素和醋酸甲孕酮)和安慰剂,并在平均5.6年的随访中测量了结果。根据这项研究,联合持续激素治疗可能对冠状动脉事件的风险几乎没有影响(RR 1.17, 95% CI 0.95至1.44;中等确定性证据)。它可能增加卒中(RR 1.39, 95% CI 1.09 - 2.09,低确定性证据)和静脉血栓栓塞(RR 2.03, 95% CI 1.55 - 6.64,低确定性证据)的风险。与安慰剂相比,联合持续激素治疗可能会增加乳腺癌的风险(RR 1.27, 95% CI 1.03至1.56;中等确定性证据),可能对肺癌的风险几乎没有影响(RR 1.06, 95% CI 0.77至1.46;中等确定性证据)。它可能增加需要手术治疗的胆囊疾病(RR 1.64, 95% CI 1.30 ~ 2.06; 14,203名受试者;低确定性证据),并可能降低所有临床骨折的风险(RR 0.78, 95% CI 0.71 ~ 0.86;中等确定性证据)。一项研究包括10,739名接受子宫切除术的绝经后妇女,将仅雌激素(结合马雌激素)激素治疗与安慰剂治疗进行比较,并在平均7年的随访中测量结果。基于这项研究,仅雌激素激素治疗可能对冠状动脉事件(RR 0.94, 95% CI 0.78至1.13)、静脉血栓栓塞(RR 1.32, 95% CI 1.00至1.74)和乳腺癌(RR 0.79, 95% CI 0.61至1.01)的风险几乎没有影响,所有这些都有中等确定性的证据。它可能对肺癌的风险几乎没有影响(RR 1.04, 95% CI 0.73至1.48;低确定性证据)。仅雌激素激素治疗可能增加卒中(RR 1.33, 95% CI 1.06 - 1.67)和胆囊疾病(RR 1.78, 95% CI 1.42 - 2.24)的风险,并可能降低所有临床骨折的风险(RR 0.73, 95% CI 0.65 - 0.80),所有证据均为中等确定性。我们判断大多数纳入的研究在大多数领域具有低偏倚风险。主要比较的证据的总体确定性是中等的。主要的限制是,只有大约30%的女性在50至59岁的基线,这个年龄组最有可能考虑血管舒缩症状的激素治疗。
{"title":"Long-term hormone therapy for perimenopausal and postmenopausal women.","authors":"Magdalena Bofill Rodriguez, Li Ning Yong, Sanja Mirkov, Christine Bekos, Anne Lethaby, Cindy Farquhar","doi":"10.1002/14651858.CD004143.pub6","DOIUrl":"10.1002/14651858.CD004143.pub6","url":null,"abstract":"<p><strong>Background: </strong>Hormone therapy is widely provided to control menopausal symptoms and has been used for the management and prevention of cardiovascular disease, osteoporosis and dementia in older women. This is an updated version of a Cochrane review first published in 2005.</p><p><strong>Objectives: </strong>To assess the long-term effects of prolonged use (at least one year) of hormone therapy on mortality, cardiovascular outcomes, cancer, gallbladder disease, fractures and cognition in perimenopausal and postmenopausal women.</p><p><strong>Search methods: </strong>We used the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, three other databases and two trial registers, together with reference checking, citation searching and contact with study authors to identify the studies included in the review. The latest search date was 26 September 2024.</p><p><strong>Selection criteria: </strong>We included randomised, double-blind trials in which peri- or postmenopausal women took hormone therapy or placebo for at least one year. We included various oestrogen formulations, with or without progestogens. We focused on studies assessing hormone therapy's effects on long-term clinical outcomes, including death, coronary events and cancer. Hormone therapy's efficacy in managing menopausal symptoms was beyond the scope of this review, and is assessed in other Cochrane reviews.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies, assessed risk of bias and extracted data. We calculated risk ratios (RRs) for dichotomous data and mean differences (MDs) for continuous data, along with 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE.</p><p><strong>Main results: </strong>We included 24 studies - with two newly added in this update - involving 45,660 participants. We derived nearly 70% of the data from two well-conducted studies: the Heart and Estrogen/progestin Replacement Study (HERS 1998) and the large, multi-component Women's Health Initiative research programme, which included two hormone therapy arms (WHI 1998). Across all the studies, most participants were postmenopausal American women with one or more comorbidities. The mean participant age in most studies was over 60 years. Only one included study focused on perimenopausal women. We present full results for all included studies with available data in the main review. The results presented below are drawn from WHI 1998, in which the combined hormone therapy arm and the oestrogen-only arm were run concurrently, with women assigned to the appropriate trial based on their uterus status. One study with 16,608 postmenopausal women with an intact uterus compared combined continuous hormone therapy (conjugated equine oestrogen and medroxyprogesterone acetate) to placebo, and measured outcomes at an average of 5.6 years of follow-up. Based on this study, combined continuous hormo","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD004143"},"PeriodicalIF":8.8,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12658958/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-27DOI: 10.1002/14651858.CD015839.pub2
Petter Darlison, Luca Moresco, Barbara Nussbaumer-Streit, Matteo Bruschettini, Marie Gisselsson-Solen
<p><strong>Rationale: </strong>Acute otitis media (AOM) is one of the most common bacterial infections in children worldwide, and the most common reason for prescribing antibiotics. Although serious complications (e.g. mastoiditis or meningitis) are rare, the infection causes acute pain and can lead to hearing impairment. Since AOM often resolves spontaneously, current treatment guidelines recommend an approach of watchful waiting (no initial antibiotics). However, decongestants and antihistamines, administered orally or nasally, might reduce inflammation and mucosal oedema in the middle ear and help resolve AOM in children.</p><p><strong>Objectives: </strong>To assess the benefits and harms of decongestants and antihistamines in treating acute otitis media in children.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, CINAHL, the World Health Organization (WHO) trials portal, and ClinicalTrials.gov in February 2025. We checked reference lists of relevant articles for additional studies.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) with children (from any setting) with AOM. Eligible comparisons were decongestants versus no intervention or placebo, antihistamines versus no intervention or placebo, decongestants plus antihistamines versus no intervention or placebo, decongestants versus antihistamines, one decongestant versus another, and one antihistamine versus another. The route of administration could be oral or nasal.</p><p><strong>Outcomes: </strong>Our critical outcomes were presence of AOM within seven days from starting treatment, severe complications (e.g. mastoiditis, meningitis, sinus thrombosis, facial paralysis, labyrinthitis), any adverse events (e.g. drowsiness), otalgia (yes/no) within seven days from starting treatment, and otalgia (score) within seven days from starting treatment. Our important outcomes included the presence of otitis media with effusion (OME) within 10 to 14 days from starting treatment.</p><p><strong>Risk of bias: </strong>Two review authors used the Cochrane risk of bias tool (RoB 2) to independently assess risk of bias.</p><p><strong>Synthesis methods: </strong>We used standard Cochrane methods. We evaluated the benefits and harms using a random-effects model, calculating risk ratios (RRs) and risk differences (RDs) with 95% confidence intervals (CIs) for dichotomous outcomes, and mean differences (MDs) or standardised mean differences (SMDs) for continuous outcomes. Where the results could not be pooled due to the nature of the data, we described them narratively. We assessed the certainty of evidence using the GRADE approach.</p><p><strong>Included studies: </strong>We identified 15 studies (3066 participants) conducted in the USA (11 studies), Denmark (2 studies), Canada (1 study), and the UK (1 study), and published between 1965 and 2003. In 12 studies, the children's ages ranged from three months to 15 years. One study also includ
05, 95% CI 0.32 ~ 3.36;1项研究,90名参与者;非常低确定性证据)。2. 一项研究的证据表明,与不干预相比,抗组胺药可能导致的严重并发症几乎没有差异(无事件;低确定性证据)。3. 与安慰剂相比,抗组胺药对任何不良事件的影响的证据非常不确定(RR 7.00, 95% CI 0.37至133.12;I²=不适用;2项研究,192名受试者;非常低确定性证据)。4. 与安慰剂相比,抗组胺药在7天内对耳痛的影响的证据非常不确定(RR 3.52, 95% CI 0.15至82.34;1项研究,48名受试者;非常低确定性证据)。5. 没有研究报告在7天内出现痛觉评分。6. 与安慰剂相比,抗组胺药可能导致10至14天内OME的存在几乎没有差异(RR 1.13, 95% CI 0.89至1.45,I²= 0%;3项研究,439名参与者;低确定性证据)。证据的确定性从低到非常低,主要是由于研究的局限性(偏倚风险)和不精确。作者的结论:对于急性中耳炎儿童口服或鼻腔减充血药或抗组胺药的益处和危害,证据非常不确定。自2003年以来,没有发表过相关的试验。没有研究正在进行中。经费:本Cochrane综述未获得专项经费。注册:协议(2023):doi.org/10.1002/14651858.CD015839。
{"title":"Decongestants and antihistamines for acute otitis media in children.","authors":"Petter Darlison, Luca Moresco, Barbara Nussbaumer-Streit, Matteo Bruschettini, Marie Gisselsson-Solen","doi":"10.1002/14651858.CD015839.pub2","DOIUrl":"10.1002/14651858.CD015839.pub2","url":null,"abstract":"<p><strong>Rationale: </strong>Acute otitis media (AOM) is one of the most common bacterial infections in children worldwide, and the most common reason for prescribing antibiotics. Although serious complications (e.g. mastoiditis or meningitis) are rare, the infection causes acute pain and can lead to hearing impairment. Since AOM often resolves spontaneously, current treatment guidelines recommend an approach of watchful waiting (no initial antibiotics). However, decongestants and antihistamines, administered orally or nasally, might reduce inflammation and mucosal oedema in the middle ear and help resolve AOM in children.</p><p><strong>Objectives: </strong>To assess the benefits and harms of decongestants and antihistamines in treating acute otitis media in children.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, CINAHL, the World Health Organization (WHO) trials portal, and ClinicalTrials.gov in February 2025. We checked reference lists of relevant articles for additional studies.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) with children (from any setting) with AOM. Eligible comparisons were decongestants versus no intervention or placebo, antihistamines versus no intervention or placebo, decongestants plus antihistamines versus no intervention or placebo, decongestants versus antihistamines, one decongestant versus another, and one antihistamine versus another. The route of administration could be oral or nasal.</p><p><strong>Outcomes: </strong>Our critical outcomes were presence of AOM within seven days from starting treatment, severe complications (e.g. mastoiditis, meningitis, sinus thrombosis, facial paralysis, labyrinthitis), any adverse events (e.g. drowsiness), otalgia (yes/no) within seven days from starting treatment, and otalgia (score) within seven days from starting treatment. Our important outcomes included the presence of otitis media with effusion (OME) within 10 to 14 days from starting treatment.</p><p><strong>Risk of bias: </strong>Two review authors used the Cochrane risk of bias tool (RoB 2) to independently assess risk of bias.</p><p><strong>Synthesis methods: </strong>We used standard Cochrane methods. We evaluated the benefits and harms using a random-effects model, calculating risk ratios (RRs) and risk differences (RDs) with 95% confidence intervals (CIs) for dichotomous outcomes, and mean differences (MDs) or standardised mean differences (SMDs) for continuous outcomes. Where the results could not be pooled due to the nature of the data, we described them narratively. We assessed the certainty of evidence using the GRADE approach.</p><p><strong>Included studies: </strong>We identified 15 studies (3066 participants) conducted in the USA (11 studies), Denmark (2 studies), Canada (1 study), and the UK (1 study), and published between 1965 and 2003. In 12 studies, the children's ages ranged from three months to 15 years. One study also includ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD015839"},"PeriodicalIF":8.8,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12658955/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630364","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-27DOI: 10.1002/14651858.CD015376.pub2
Giovana Vesentini, Nicole O'Connor, Mélanie Le Berre, Ashraf F Nabhan, Adrian Wagg, Sheila A Wallace, Chantale Dumoulin
<p><strong>Background: </strong>Urinary incontinence is highly prevalent among women 60 years and over, impacting their quality of life. The condition is often overlooked and untreated. Various treatments are available, but their benefits and harms in older women remain uncertain.</p><p><strong>Objectives: </strong>To compare the benefits and harms of conservative, pharmacological, and surgical treatments for urinary incontinence in terms of 'cure', 'cure or improvement', and serious adverse events (SAEs) in women 60 years and over using network meta-analyses (NMA), and to rank interventions within a single treatment network.</p><p><strong>Search methods: </strong>We searched the Cochrane Incontinence Specialized Register, comprising trials from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, MEDLINE Daily, and two major international clinical trial registries, on 23 March 2025. We handsearched journals, conference proceedings, and reference lists of relevant articles. We placed no limitations on the searches.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials (RCTs) that examined the benefits and harms of conservative, pharmacological, and/or surgical treatments in women 60 years and over with urinary incontinence. Our primary outcomes were 'cure' and 'cure or improvement' of urinary incontinence symptoms. Secondary outcomes included the number of women with SAEs.</p><p><strong>Data collection and analysis: </strong>At least two review authors independently assessed trials for eligibility and risk of bias using Cochrane's risk of bias 2 (RoB 2) tool. A third author resolved any disagreements. We followed the guidance on undertaking NMA in Chapter 11 of the Cochrane Handbook for Systematic Reviews of Interventions.</p><p><strong>Main results: </strong>We included 43 RCTs involving 8506 participants, a mean of 198 per study (range 14 to 1438). Conservative treatments predominated (20/43, 46.5%) in the studies, followed by pharmacological (17/43, 39.5%), surgical (4/43, 9.3%), and mixed (2/43, 4.7%) treatments. The RCTs had variable risks of bias, often presenting 'some concerns' or 'high risk,' with poor reporting on randomization, blinding, and protocol details. Conservative and pharmacological treatments were often at a high risk of bias for all outcomes (cure, cure or improvement, and SAEs). For the 'cure' outcome, we excluded three studies to address network disconnections; hence, comparisons focused on conservative and pharmacological treatments. Results indicated that all treatments might be better than control, with physical therapies - mainly pelvic floor muscle training with or without complementary therapies or education - showing the best performance for 'cure': physical therapies combined with complementary therapies (odds ratio (OR) 17.79, 95% confidence interval (CI) 2.97 to 106.46; 1 study, 71 participants), physical therapies (OR 7.20, 95% CI 2.59 to 20.03; 4 studies, 310 particip
背景:尿失禁在60岁及以上的女性中非常普遍,影响她们的生活质量。这种情况经常被忽视和治疗。有各种各样的治疗方法,但它们对老年妇女的益处和危害仍不确定。目的:利用网络荟萃分析(NMA)比较60岁及以上女性尿失禁的保守、药物和手术治疗在“治愈”、“治愈或改善”和严重不良事件(sae)方面的利弊,并在单一治疗网络中对干预措施进行排名。检索方法:我们检索了Cochrane失禁专业注册库,包括CENTRAL、MEDLINE、MEDLINE In-Process、MEDLINE Epub Ahead of Print、MEDLINE Daily和两个主要的国际临床试验注册库的试验,检索时间为2025年3月23日。我们手工检索了期刊、会议记录和相关文章的参考书目。我们对搜索没有任何限制。选择标准:我们纳入了随机对照试验(RCTs),这些试验检查了60岁及以上女性尿失禁的保守、药物和/或手术治疗的利弊。我们的主要结局是尿失禁症状的“治愈”和“治愈或改善”。次要结局包括发生急性呼吸窘迫症的妇女人数。数据收集和分析:至少有两位综述作者使用Cochrane’s risk of bias 2 (RoB 2)工具独立评估了试验的合格性和偏倚风险。第三位作者解决了任何分歧。我们遵循Cochrane干预措施系统评价手册第11章对NMA的指导。主要结果:我们纳入了43项随机对照试验,涉及8506名受试者,平均每项研究198人(范围14至1438)。研究中以保守治疗为主(20/43,46.5%),其次是药物治疗(17/43,39.5%)、手术治疗(4/43,9.3%)和混合治疗(2/43,4.7%)。随机对照试验具有不同的偏倚风险,通常表现为“一些担忧”或“高风险”,对随机化、盲法和方案细节的报道较差。保守治疗和药物治疗在所有结果(治愈、治愈或改善和SAEs)中往往存在较高的偏倚风险。对于“治愈”结果,我们排除了三个解决网络断开的研究;因此,比较集中于保守治疗和药物治疗。结果表明,所有治疗方法均优于对照组,其中物理治疗(主要是盆底肌肉训练,配合或不配合辅助治疗或教育)在“治愈”方面表现最佳:物理治疗联合辅助治疗(优势比(or) 17.79, 95%可信区间(CI) 2.97至106.46;研究中,71名参与者)、物理疗法(或7.20,95%可信区间2.59到20.03;4研究中,310名参与者),和物理治疗与教育(或3.25,95%可信区间1.19到8.84;4研究中,364名参与者),所有三个结果的证据是非常低的确定性,紧随其后的是补充疗法(1或4.65,95%可信区间0.74到29.37;研究中,37个参与者;非常低确定性的证据)和教育(或2.68,95%可信区间0.61到11.73;2研究中,180名参与者,确定性的证据)。最佳治疗的平均排名、P评分和累积排名曲线下的表面(SUCRA)值显示了物理治疗的优越性,表明补充治疗可能是“治愈”的最佳治疗方法(包括物理治疗在内的三种干预措施的SUCRA值范围为57%至85%)。然而,由于效果估计不精确和数据稀疏,关于最佳治疗的不确定性仍然存在(低到极低确定性的证据)。对于“治愈或改善尿失禁”,通过排除3项研究调整了不相关的网络后,分析显示,与对照组相比,有或没有教育的物理疗法效果最好,所有以下结果的证据都很低(物理疗法:or 3.98, 95% CI 2.02至7.82;3项研究,197名参与者;物理疗法结合教育:or 3.20, 95% CI 1.45至7.02;3项研究,236名参与者;β3-肾上腺素能激动剂:OR 2.44, 95% CI 1.28 - 4.62;1项研究,360名受试者),其次是教育(OR 2.09, 95% CI 1.05至4.17;2项研究,213名受试者)和抗毒药物(OR 1.90, 95% CI 1.19至3.03;2项研究,1469名受试者)。与对照组相比,物理疗法(有或没有教育干预)和β3-肾上腺素能激动剂的效果最好(物理疗法:SUCRA = 90%;物理疗法结合教育:SUCRA = 77%; β3-肾上腺素能激动剂:SUCRA = 63%)。然而,证据的确定性非常低,表明需要进行更多的试验。值得注意的是,在保守治疗中没有出现不良反应,而药物治疗中也出现了一些不良反应。 然而,没有任何治疗显示SAEs发生的几率明显降低,以下所有结果的证据都很低(5 -羟色胺-去甲肾上腺素摄取抑制剂:OR 0.40, 95% CI 0.10至1.59,1项研究,264名受试者;β3-肾上腺素激动剂:OR 0.61, 95% CI 0.04至10.19,1项研究,404名受试者;补充治疗:OR 0.53, 95% CI 0.00至71.04,无直接证据,18名受试者;抗毒碱药物:OR 0.81, 95% CI 0.46至1.42,4项研究,2731名受试者;物理治疗结合教育:OR 0.99, 95% CI 0.10 ~ 9.80;3项研究,130名参与者)。作者的结论:由于试验数量有限,通常样本量较小,关于治疗益处和危害的估计精度较低。我们成功地进行了NMA,但没有足够的证据来支持一个强有力的整体分析。为了建立一个连接的治疗网络,我们排除了手术干预研究。因此,分析集中在保守治疗和药物治疗的比较上。对于“治愈”的结果,被评为非常低到低确定性的证据表明,物理治疗结合补充治疗可能是最有效的选择,其次是物理治疗单独或结合教育。对于“治愈或改善”,物理疗法(有或没有教育)和β3-肾上腺素能激动剂都显示出潜在的益处。保守干预没有出现SAEs,而大多数药物治疗研究报告了一些。然而,没有足够的证据来确定是否有任何治疗可以降低SAEs的可能性。总的来说,研究的数量和质量不足以得出关于老年妇女尿失禁最有效治疗的确切结论。为了加强证据基础,需要进行规模更大、质量更高、干预措施定义明确、结果报告一致的试验。
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Pub Date : 2025-11-27DOI: 10.1002/14651858.CD016309
Melissa Atkinson-Graham, Silvano Mior, Nora Bakaa, Theodore Konstantinidis, Jessica Wong, Chiara Arienti, Irene Battel, Paolo Capodaglio, Claudio Cordani, Simon Décary, Wouter De Groote, Matteo Johann Del Furia, Antony Duttine, Eshetu Haileselassie Engeda, Walter R Frontera, Carlotte Kiekens, Francesca Gimigliano, Sara Liguori, Silvia Minozzi, Qhayiya Mudau, Marco Paoletta, Rebecca Ryan, Carla Sabariego, Alex Todhunter-Brown, Dima Touhami, Stefano Negrini, Pierre Côté
<p><strong>Background: </strong>Cochrane Rehabilitation and the World Health Organization (WHO) Rehabilitation Programme have collaborated to produce four Cochrane overviews of systematic reviews that synthesize current available evidence from health policy and systems research (HPSR) in rehabilitation. Each overview focuses on one of the four pillars of HPSR as identified by the Cochrane Effective Practice and Organisation of Care (EPOC) taxonomy: delivery arrangements, financial arrangements, governance arrangements, and implementation strategies. This overview focuses on governance arrangements, defined in the EPOC taxonomy as the rules or processes that affect the way in which powers are exercised, particularly regarding authority, accountability, openness, participation, and coherence.</p><p><strong>Objectives: </strong>This overview aimed to synthesize the current evidence on governance arrangements in rehabilitation from a health policy and systems research (HPSR) perspective. Our series of four overviews, incorporating evidence on governance arrangements, delivery arrangements, financial arrangements, and implementation strategies, have the following overarching objectives. • To offer a broad synthesis of the existing evidence on health policy and systems interventions' effects. • To direct end-users, including policymakers, towards systematic reviews that may address their health policy questions. • To identify current research gaps and set priorities for future primary HPSR. • To pinpoint the needs and priorities for new evidence syntheses where no reliable, up-to-date systematic reviews currently exist.</p><p><strong>Methods: </strong>We searched the Epistemonokos database, the Health Systems Evidence database, and EPOC Group systematic reviews to identify reviews published between 1 January 2015 and 17 November 2024. We applied no language limitations. We included Cochrane and non-Cochrane systematic reviews of randomized controlled trials (RCTs) and selected non-randomized studies of interventions (NRSIs) that evaluated the effectiveness of health policy and systems interventions for rehabilitation in health systems, specifically related to governance arrangements as defined in the EPOC taxonomy. All four overview teams collaborated to screen reviews and extract data. We used AMSTAR-2 to critically appraise the quality of the reviews. Reviews with ratings of high-to-moderate confidence are reported separately from low-confidence reviews.</p><p><strong>Main results: </strong>We found no Cochrane or non-Cochrane systematic reviews of RCTs or NRSIs pertaining to rehabilitation and relevant to the EPOC pillar of governance arrangements. As a result, we are unable to offer a broad synthesis of the existing evidence or to signpost relevant reviews on health policy and systems interventions related to this pillar for end-users. We did describe relevant research gaps and priorities for future primary HPSR in the rehabilitation field.</p><p><
{"title":"Governance arrangements for rehabilitation services in health systems: an overview of systematic reviews.","authors":"Melissa Atkinson-Graham, Silvano Mior, Nora Bakaa, Theodore Konstantinidis, Jessica Wong, Chiara Arienti, Irene Battel, Paolo Capodaglio, Claudio Cordani, Simon Décary, Wouter De Groote, Matteo Johann Del Furia, Antony Duttine, Eshetu Haileselassie Engeda, Walter R Frontera, Carlotte Kiekens, Francesca Gimigliano, Sara Liguori, Silvia Minozzi, Qhayiya Mudau, Marco Paoletta, Rebecca Ryan, Carla Sabariego, Alex Todhunter-Brown, Dima Touhami, Stefano Negrini, Pierre Côté","doi":"10.1002/14651858.CD016309","DOIUrl":"10.1002/14651858.CD016309","url":null,"abstract":"<p><strong>Background: </strong>Cochrane Rehabilitation and the World Health Organization (WHO) Rehabilitation Programme have collaborated to produce four Cochrane overviews of systematic reviews that synthesize current available evidence from health policy and systems research (HPSR) in rehabilitation. Each overview focuses on one of the four pillars of HPSR as identified by the Cochrane Effective Practice and Organisation of Care (EPOC) taxonomy: delivery arrangements, financial arrangements, governance arrangements, and implementation strategies. This overview focuses on governance arrangements, defined in the EPOC taxonomy as the rules or processes that affect the way in which powers are exercised, particularly regarding authority, accountability, openness, participation, and coherence.</p><p><strong>Objectives: </strong>This overview aimed to synthesize the current evidence on governance arrangements in rehabilitation from a health policy and systems research (HPSR) perspective. Our series of four overviews, incorporating evidence on governance arrangements, delivery arrangements, financial arrangements, and implementation strategies, have the following overarching objectives. • To offer a broad synthesis of the existing evidence on health policy and systems interventions' effects. • To direct end-users, including policymakers, towards systematic reviews that may address their health policy questions. • To identify current research gaps and set priorities for future primary HPSR. • To pinpoint the needs and priorities for new evidence syntheses where no reliable, up-to-date systematic reviews currently exist.</p><p><strong>Methods: </strong>We searched the Epistemonokos database, the Health Systems Evidence database, and EPOC Group systematic reviews to identify reviews published between 1 January 2015 and 17 November 2024. We applied no language limitations. We included Cochrane and non-Cochrane systematic reviews of randomized controlled trials (RCTs) and selected non-randomized studies of interventions (NRSIs) that evaluated the effectiveness of health policy and systems interventions for rehabilitation in health systems, specifically related to governance arrangements as defined in the EPOC taxonomy. All four overview teams collaborated to screen reviews and extract data. We used AMSTAR-2 to critically appraise the quality of the reviews. Reviews with ratings of high-to-moderate confidence are reported separately from low-confidence reviews.</p><p><strong>Main results: </strong>We found no Cochrane or non-Cochrane systematic reviews of RCTs or NRSIs pertaining to rehabilitation and relevant to the EPOC pillar of governance arrangements. As a result, we are unable to offer a broad synthesis of the existing evidence or to signpost relevant reviews on health policy and systems interventions related to this pillar for end-users. We did describe relevant research gaps and priorities for future primary HPSR in the rehabilitation field.</p><p><","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD016309"},"PeriodicalIF":8.8,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12658954/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630390","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-26DOI: 10.1002/14651858.CD011852.pub2
Judith D de Rooij, Arianne P Verhagen, B S Harhangi, Michael G Fehlings, J George Groeneweg, Wichor M Bramer, Frank J Huygen, Miranda W Langendam
<p><strong>Background: </strong>Cervical radicular pain due to disc herniation presents with pain in the neck and one arm, with muscle weakness with or without numbness or tingling in the fingers or hands. Conservative treatment includes rest, analgesics, non-steroidal anti-inflammatory drugs, exercises and cervical collar. When conservative treatment fails, surgery is considered. Surgery can carry risks, and freedom from pain is not guaranteed. Recently, nucleoplasty, a new treatment for contained disc herniations, was developed. Nucleoplasty is a minimally invasive outpatient procedure that relieves nerve pressure by removing small portions of the disc's gel-like nucleus, with no reported neurological complications.</p><p><strong>Objectives: </strong>To assess the effect of nucleoplasty on pain, function, quality of life, recovery, adverse events and withdrawals due to adverse events compared to placebo, no treatment, conservative treatment, minimally invasive interventions or surgery for people with cervical radicular pain due to disc herniation.</p><p><strong>Search methods: </strong>We used CENTRAL, MEDLINE, seven other databases and two trial registers, together with reference checking, citation searching and contact with study authors and experts in the field to identify the studies that are included in the review. The latest search date was 24 February 2025.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) that investigated nucleoplasty compared to placebo/sham treatment, no treatment, conservative treatment, minimally-invasive interventions or surgery for people with cervical radicular pain due to disc herniation. Major outcomes were pain in the arm and neck, neck-related function, recovery, quality of life, adverse events and withdrawals due to adverse events. The primary time point was short-term follow-up (up to three months).</p><p><strong>Data collection and analysis: </strong>Two review authors independently screened the references. We used the original Cochrane risk of bias tool for RCTs to assess the risk of bias of the included studies. We used GRADE to assess the certainty of the evidence.</p><p><strong>Main results: </strong>We included four RCTs (259 participants). We judged all four studies to have an overall high risk of bias, due either to a high risk of detection or attrition bias. Three of four studies were at high risk of detection bias for unblinded outcome assessors. Nucleoplasty versus no treatment or placebo We did not find any RCT for this comparison. Nucleoplasty versus conservative treatment (1 study, 120 participants) Low-certainty evidence, downgraded for risk of bias and imprecision, showed that nucleoplasty may result in a large reduction in pain (0 to 100 scale, 0 = no pain) at short-term follow-up. The mean change from baseline in pain was 30.45 points lower with conservative treatment and 53.16 points lower with nucleoplasty (mean difference (MD) 22.71 points lower
背景:椎间盘突出引起的颈椎神经根性疼痛表现为颈部和单臂疼痛,伴有肌肉无力,伴或不伴手指或手部麻木或刺痛。保守治疗包括休息、镇痛药、非甾体类抗炎药、运动和颈套。当保守治疗失败时,考虑手术治疗。手术是有风险的,而且不能保证没有疼痛。最近,核成形术,一种新的治疗包治性椎间盘突出的方法,被开发出来。核成形术是一种微创门诊手术,通过切除一小部分椎间盘凝胶状核来减轻神经压力,无神经系统并发症报道。目的:与安慰剂、不治疗、保守治疗、微创干预或手术治疗相比,评估核成形术对椎间盘突出所致颈根性疼痛患者的疼痛、功能、生活质量、恢复、不良事件和因不良事件而退出的影响。检索方法:我们使用CENTRAL、MEDLINE等7个数据库和2个试验注册库,结合参考文献检查、引文检索和联系研究作者和该领域的专家来确定纳入综述的研究。最近一次搜索日期是2025年2月24日。选择标准:我们纳入了随机对照试验(RCTs),研究了核成形术与安慰剂/假治疗、不治疗、保守治疗、微创干预或手术治疗椎间盘突出引起的颈根性疼痛患者的比较。主要结局是手臂和颈部疼痛、颈部相关功能、恢复、生活质量、不良事件和因不良事件而退出。主要时间点为短期随访(最长3个月)。资料收集和分析:两位综述作者独立筛选了参考文献。我们使用原始的Cochrane随机对照试验偏倚风险工具来评估纳入研究的偏倚风险。我们使用GRADE来评估证据的确定性。主要结果:我们纳入了4项随机对照试验(259名受试者)。我们判断这四项研究总体偏倚风险高,原因是检测风险高或损耗偏倚高。对于非盲法结果评估者,四项研究中有三项存在检测偏倚的高风险。核成形术与不治疗或安慰剂相比,我们没有发现任何RCT进行这种比较。核成形术与保守治疗(1项研究,120名受试者)低确定性证据(因风险偏倚和不精确而降级)显示,核成形术可在短期随访中显著减轻疼痛(0至100分,0 =无疼痛)。与基线相比,保守治疗的疼痛平均变化降低30.45分,核成形术的疼痛平均变化降低53.16分(平均差值(MD)降低22.71分(95%可信区间(CI)降低30.10至15.32分)。低确定性证据(因偏倚风险和不精确而降级)显示,核成形术在短期随访中可能不会导致颈部相关功能的差异(颈部残疾指数(NDI) 0至50,得分越低表明残疾越少)。保守治疗组和核成形术组相对基线功能的平均变化比前者低9.27点和11.75点(MD降低2.48,95% CI降低5.11至0.15)。低确定性证据显示,与保守治疗相比,核成形术可能在短期内导致生活质量几乎没有差异(36项简短健康调查,心理成分总结(sf - 36mcs), 0到100,100 =最高分)。与基线相比,保守治疗的平均生活质量变化为8.04分,核成形术的平均生活质量变化为6.31分(MD降低1.73,95% CI降低5.32至1.86)。与保守治疗相比,尚不确定核成形术是否会增加不良反应的风险。这项研究没有报告康复情况,也没有停药。核成形术与脉冲射频背根神经节(1项研究,34名参与者)相比,我们不确定核成形术是否对疼痛(0至100分,0 =无痛;MD低7.9,95% CI低29.45至高13.65)、颈部相关功能(0至50分,0 =最高分;在短期随访中,由于非常低的确定性证据(因偏倚、不精确和间接风险降级),MD高0.30,95% CI 6.97低至7.57高),恢复(MD低5.10,95% CI 29.92低至19.72高)或不良事件(风险比(RR) 1.0, 95% CI 0.17至5.83)。核成形术与椎间盘切除术(2项研究,105名受试者)低确定性证据,因风险偏倚和不精确而降级,显示核成形术在短期随访中可能导致颈部疼痛几乎没有差异(MD高0.33点,95% CI低0.36至高1.03点)。我们不确定核成形术是否对手臂疼痛有任何影响。 74点低,95% CI 1.23降低到0.25低),neck-related函数(MD 0.69点低,95% CI 12.63降低到11.25更高),恢复(相对危险度0.81,95%可信区间0.51到1.29,1个随机对照试验,48参与者),生活质量(MD高出0.83,95% CI 8.47低10.13高;1个随机对照试验,48参与者)或不良事件(相对危险度0.14,95%可信区间0.01到2.62)相比,椎间盘切除术在短期随访,由于确定性的证据将偏差的风险,不精确和模棱两可。没有因不良事件而停药的报告。作者的结论是:与保守治疗相比,在短期随访中,低确定性的证据表明核成形术可以大大减轻疼痛,并且颈部相关功能没有差异。对于其他比较(背根神经节的脉冲射频,椎间盘切除术),有低到极低确定性的证据表明核成形术对疼痛,颈部相关功能,恢复或不良事件几乎没有影响。核成形术组和对照组均未发生严重并发症。没有足够的证据支持核成形术治疗椎间盘突出引起的神经根性疼痛。我们需要足够有力、设计良好的随机对照试验。
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Pub Date : 2025-11-25DOI: 10.1002/14651858.CD016058.pub3
Ailsa R Butler, Nicola Lindson, Jonathan Livingstone-Banks, Caitlin Notley, Tari Turner, Nancy A Rigotti, Thomas R Fanshawe, Rachna Begh, Angela Difeng Wu, Leonie Brose, Monserrat Conde, Erikas Simonavičius, Jamie Hartmann-Boyce
<p><strong>Rationale: </strong>There is limited guidance on how to stop using nicotine-containing vapes (otherwise known as e-cigarettes) and ensure long-term abstinence, whilst minimising the risk of tobacco smoking and other unintended consequences. Treatments could include pharmacological interventions, behavioural interventions, or both.</p><p><strong>Objectives: </strong>To conduct a living systematic review assessing the benefits and harms of interventions to help people stop vaping compared to each other, placebo or no intervention. To assess how these interventions affect the use of combustible tobacco, and whether effects vary based on participant characteristics.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, PsycINFO, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform from 1 January 2004 to 1 July 2025. We also searched the references of eligible studies and abstracts from the Society for Research on Nicotine and Tobacco conferences, and contacted study authors.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) recruiting people of any age using nicotine-containing vapes, regardless of tobacco smoking status. Studies had to test an intervention designed to support people to quit vaping, and plan to measure at least one of our outcomes.</p><p><strong>Outcomes: </strong>Critical outcomes: vaping cessation at six months or longer; change in combustible tobacco use at six months or longer; number of participants reporting serious adverse events (SAEs) at one week or longer.</p><p><strong>Risk of bias: </strong>We used Cochrane's RoB 1 tool to assess risk of bias in the included studies.</p><p><strong>Synthesis methods: </strong>We followed standard Cochrane methods. We grouped studies by comparisons and outcomes, and calculated individual study and pooled effects, as appropriate. We used random-effects Mantel-Haenszel methods to calculate risk ratios (RRs) with 95% confidence intervals (CIs) and random-effects inverse variance methods to calculate mean differences (MDs) and 95% CIs. We used GRADE to assess the certainty of evidence for our critical outcomes.</p><p><strong>Included studies: </strong>Fifteen studies (six new to this updated version) involving 5800 participants are included. Fourteen studies included some participants who had previously smoked tobacco; in seven studies, participants were not smoking at baseline. Twelve studies only included participants aged 18 or older (five exclusively included people between 18 and 29); two included some participants under 18 years; and one included 13- to 17-year-olds only. Fourteen studies were conducted in the USA and one in Italy. We judged five studies at low, six at high, and four at unclear risk of bias.</p><p><strong>Synthesis of results: </strong>Pharmacological interventions Studies assessed our critical outcomes in relation to combination nicotine replacement therapy (NRT), cytisine,
理由:关于如何停止使用含尼古丁的电子烟(也称为电子烟)并确保长期戒烟,同时最大限度地减少吸烟风险和其他意想不到的后果,目前的指导有限。治疗包括药物干预、行为干预或两者兼而有之。目的:进行一项实时系统综述,评估帮助人们戒烟的干预措施与其他干预措施、安慰剂或不干预措施相比的利弊。评估这些干预措施如何影响可燃烟草的使用,以及影响是否因参与者的特征而异。检索方法:检索2004年1月1日至2025年7月1日的CENTRAL、MEDLINE、Embase、PsycINFO、ClinicalTrials.gov和WHO国际临床试验注册平台。我们还检索了符合条件的研究参考文献和尼古丁与烟草研究协会会议的摘要,并联系了研究作者。入选标准:我们纳入了随机对照试验(RCTs),招募任何年龄的人使用含尼古丁的电子烟,无论吸烟状况如何。研究必须测试一种旨在支持人们戒烟的干预措施,并计划衡量我们的至少一项结果。关键结果:戒烟6个月或更长时间;6个月或更长时间内可燃烟草使用的变化;在一周或更长时间内报告严重不良事件(SAEs)的参与者数量。偏倚风险:我们使用Cochrane的RoB 1工具评估纳入研究的偏倚风险。合成方法:采用标准Cochrane方法。我们根据比较和结果对研究进行分组,并酌情计算单个研究和汇总效应。我们使用随机效应Mantel-Haenszel方法计算95%置信区间(ci)的风险比(rr),使用随机效应反方差方法计算平均差异(MDs)和95% ci。我们使用GRADE来评估关键结果证据的确定性。纳入的研究:纳入了15项研究(6项是本更新版本的新研究),涉及5800名参与者。14项研究包括一些以前吸烟的参与者;在七项研究中,参与者在基线时不吸烟。12项研究只包括18岁或以上的参与者(5项研究只包括18至29岁的人);其中两项包括一些18岁以下的参与者;其中一项仅包括13至17岁的青少年。14项研究在美国进行,1项在意大利进行。我们判定5项研究为低偏倚风险,6项为高偏倚风险,4项为不明确偏倚风险。综合结果:药理干预研究评估了与安慰剂或无/最小支持相比,尼古丁替代疗法(NRT)、胱氨酸和伐尼克兰联合治疗的关键结果。对于联合NRT与无/最小支持相比,没有明确的证据表明在6个月或更长时间内戒烟率有好处,CI包含了戒烟率降低和增加的可能性(由于不精确和偏倚风险,证据的确定性非常低;RR 0.96, 95% CI 0.73至1.25;I²= 0%;2项研究,214名参与者)。一项调查胱氨酸与安慰剂的研究没有报告在6个月或更长时间内戒烟。与安慰剂相比,伐尼克兰在6个月时增加了戒烟率,但由于不精确,证据的确定性较低(RR 2.71, 95% CI 1.33至5.49;I2 = 48%; 2项研究,315名参与者)。一项比较联合NRT与无/最低支持的可燃戒烟的研究报告。没有明确的证据表明两组的戒烟率较高,ci也不精确。由于不精确和偏倚风险,证据的确定性非常低(RR 0.99, 95% CI 0.71至1.37;198名受试者)。在两项调查联合NRT与无/最低支持的研究(706名参与者;由于存在偏倚和不精确的风险,证据非常低确定性)和一项调查胱氨酸与安慰剂的研究(159名参与者;由于不精确,证据低确定性)中,零参与者报告了sae。四项评估伐尼克兰与安慰剂的研究测量了SAEs,其中两项研究报告了零事件。因此,我们的效应估计是基于两项研究(RR 2.82, 95% CI 0.45 - 17.59; 304名受试者;由于不精确,证据的确定性较低)。行为干预研究评估了我们的关键结果,与减少尼古丁/电子烟行为和基于短信的干预相比,没有/很少的支持。没有明确的证据表明,与最小支持相比,尼古丁/电子烟减少在6个月时增加了电子烟戒烟(RR 3.38, 95% CI 0.43至26.30;1项研究,17名参与者;由于不精确和偏倚风险,证据的确定性非常低)。 有低确定性的证据(由于间接)表明,在13至24岁的青少年中,与没有或只有很少的支持相比,基于短信的干预可能会增加戒烟率(RR 1.32, 95% CI 1.19至1.47;I2 = 0%; 2项研究,4091名参与者)。有非常低确定性的证据(由于间接和不精确)表明,与没有或很少支持相比,基于短信的戒烟干预可能导致吸烟摄入(RR 1.04, 95% CI 0.81至1.33;1项研究,1036名参与者)或戒烟(RR 1.03, 95% CI 0.90至1.19;1项研究,793名参与者)几乎没有差异。一项调查尼古丁/电子烟行为减少与最小支持的研究没有报告急性脑损伤。三项调查基于短信的干预措施的研究报告了SAEs;然而,零事件被报道(2082名参与者;由于不精确,证据的确定性较低)。作者的结论是:低确定性的证据表明,与没有或只有很少的支持相比,基于短信的干预措施帮助人们戒烟可能会帮助更多的青少年和年轻人成功戒烟,而关于它们对吸烟行为的影响的证据非常不确定。不确定的证据表明,伐尼克兰可能有助于人们戒烟。由于存在偏倚和不精确的风险,探索NRT、胱氨酸和尼古丁/电子烟行为减少联合使用的有效性的数据尚无定论。大多数测量SAEs的研究报告没有发生;然而,需要更多的数据来得出明确的结论。对这些戒烟干预措施进行调查的研究并没有显示出对SAEs的严重担忧。重要的是,未来的研究应测量可燃烟草的结果,以便考虑相关干预措施的完整风险概况。进一步的随机对照试验正在进行中。为了确保本综述继续为决策者提供最新信息,我们将通过每月进行搜索并在出现加强或改变我们结论的相关新证据时更新综述,将其作为一项活的系统综述。资助:英国癌症研究中心(piccr -2024/100012);国家卫生和保健研究所(NIHR206123)。注册:协议(2024)DOI: 10.1002/14651858。CD016058原综述(2025)DOI: 10.002 /14651858.CD016058.pub2。
{"title":"Interventions for quitting vaping.","authors":"Ailsa R Butler, Nicola Lindson, Jonathan Livingstone-Banks, Caitlin Notley, Tari Turner, Nancy A Rigotti, Thomas R Fanshawe, Rachna Begh, Angela Difeng Wu, Leonie Brose, Monserrat Conde, Erikas Simonavičius, Jamie Hartmann-Boyce","doi":"10.1002/14651858.CD016058.pub3","DOIUrl":"10.1002/14651858.CD016058.pub3","url":null,"abstract":"<p><strong>Rationale: </strong>There is limited guidance on how to stop using nicotine-containing vapes (otherwise known as e-cigarettes) and ensure long-term abstinence, whilst minimising the risk of tobacco smoking and other unintended consequences. Treatments could include pharmacological interventions, behavioural interventions, or both.</p><p><strong>Objectives: </strong>To conduct a living systematic review assessing the benefits and harms of interventions to help people stop vaping compared to each other, placebo or no intervention. To assess how these interventions affect the use of combustible tobacco, and whether effects vary based on participant characteristics.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, PsycINFO, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform from 1 January 2004 to 1 July 2025. We also searched the references of eligible studies and abstracts from the Society for Research on Nicotine and Tobacco conferences, and contacted study authors.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) recruiting people of any age using nicotine-containing vapes, regardless of tobacco smoking status. Studies had to test an intervention designed to support people to quit vaping, and plan to measure at least one of our outcomes.</p><p><strong>Outcomes: </strong>Critical outcomes: vaping cessation at six months or longer; change in combustible tobacco use at six months or longer; number of participants reporting serious adverse events (SAEs) at one week or longer.</p><p><strong>Risk of bias: </strong>We used Cochrane's RoB 1 tool to assess risk of bias in the included studies.</p><p><strong>Synthesis methods: </strong>We followed standard Cochrane methods. We grouped studies by comparisons and outcomes, and calculated individual study and pooled effects, as appropriate. We used random-effects Mantel-Haenszel methods to calculate risk ratios (RRs) with 95% confidence intervals (CIs) and random-effects inverse variance methods to calculate mean differences (MDs) and 95% CIs. We used GRADE to assess the certainty of evidence for our critical outcomes.</p><p><strong>Included studies: </strong>Fifteen studies (six new to this updated version) involving 5800 participants are included. Fourteen studies included some participants who had previously smoked tobacco; in seven studies, participants were not smoking at baseline. Twelve studies only included participants aged 18 or older (five exclusively included people between 18 and 29); two included some participants under 18 years; and one included 13- to 17-year-olds only. Fourteen studies were conducted in the USA and one in Italy. We judged five studies at low, six at high, and four at unclear risk of bias.</p><p><strong>Synthesis of results: </strong>Pharmacological interventions Studies assessed our critical outcomes in relation to combination nicotine replacement therapy (NRT), cytisine,","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD016058"},"PeriodicalIF":8.8,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12645533/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145602744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}