Pub Date : 2025-03-11DOI: 10.1002/14651858.CD013874.pub3
Graziella Filippini, Jera Kruja, Cinzia Del Giovane
<p><strong>Background: </strong>Multiple sclerosis (MS) is the most common neurological cause of disability in young adults. Off-label rituximab for MS is used in most countries surveyed by the International Federation of MS, including high-income countries where on-label disease-modifying treatments (DMTs) are available. This updates the 2021 version of the review.</p><p><strong>Objectives: </strong>To assess the benefits and harms of rituximab as 'first choice' and 'switching' treatment for adults with any form of MS.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, CINAHL, and three trials registers on 31 December 2023, together with reference checking and contacting study authors to identify unpublished studies.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) and controlled non-randomised studies of interventions (NRSIs) comparing rituximab with placebo or another DMT for adults with any form of MS.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methods. We used RoB 1 to assess risk of bias in RCTs and ROBINS-I in NRSIs. We assessed the certainty of evidence for critical and important prioritised outcomes using GRADE: disability worsening, relapse, serious adverse events (SAEs), health-related quality of life (HRQoL), common infections, cancer, and mortality. We conducted separate analyses for rituximab as 'first choice' or as 'switching' treatment, relapsing or progressive MS, comparison with placebo or another DMT, and RCTs or NRSIs.</p><p><strong>Main results: </strong>In this update, the number of study participants increased from 16,429 (15 studies) to 37,443 (28 studies; 13 new studies: 1 RCT and 12 NRSIs). The studies were conducted worldwide; most originated from high-income countries (25 studies). Public institutions funded 22 (79%) of the studies. Most studies investigated the effects of rituximab on people with relapsing MS (19 studies; 27,500 (73%) participants). We identified 12 ongoing studies. Rituximab as 'first choice' for active relapsing MS None of the included studies compared rituximab to placebo. One RCT compared rituximab to dimethyl fumarate, with 24 months' follow-up. Rituximab may reduce the recurrence of relapse (odds ratio (OR) 0.16, 95% confidence interval (CI) 0.04 to 0.57; 195 participants; low-certainty evidence). The evidence is very uncertain on disability worsening and SAEs. Rituximab may result in little to no difference in upper respiratory tract infections (rate ratio (RR) 1.03, 95% CI 0.79 to 1.34; low-certainty evidence). The evidence is very uncertain for urinary tract, skin, and viral infections. HRQoL, cancer, and mortality were not reported. One NRSI compared rituximab to other DMTs, with 24 months' follow-up. Disability worsening was not reported. Compared with interferon beta or glatiramer acetate, rituximab likely delays relapse (hazard ratio (HR) 0.14, 95% CI 0.05 to 0.39; 1 study, 335 part
{"title":"Rituximab for people with multiple sclerosis.","authors":"Graziella Filippini, Jera Kruja, Cinzia Del Giovane","doi":"10.1002/14651858.CD013874.pub3","DOIUrl":"10.1002/14651858.CD013874.pub3","url":null,"abstract":"<p><strong>Background: </strong>Multiple sclerosis (MS) is the most common neurological cause of disability in young adults. Off-label rituximab for MS is used in most countries surveyed by the International Federation of MS, including high-income countries where on-label disease-modifying treatments (DMTs) are available. This updates the 2021 version of the review.</p><p><strong>Objectives: </strong>To assess the benefits and harms of rituximab as 'first choice' and 'switching' treatment for adults with any form of MS.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, CINAHL, and three trials registers on 31 December 2023, together with reference checking and contacting study authors to identify unpublished studies.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) and controlled non-randomised studies of interventions (NRSIs) comparing rituximab with placebo or another DMT for adults with any form of MS.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methods. We used RoB 1 to assess risk of bias in RCTs and ROBINS-I in NRSIs. We assessed the certainty of evidence for critical and important prioritised outcomes using GRADE: disability worsening, relapse, serious adverse events (SAEs), health-related quality of life (HRQoL), common infections, cancer, and mortality. We conducted separate analyses for rituximab as 'first choice' or as 'switching' treatment, relapsing or progressive MS, comparison with placebo or another DMT, and RCTs or NRSIs.</p><p><strong>Main results: </strong>In this update, the number of study participants increased from 16,429 (15 studies) to 37,443 (28 studies; 13 new studies: 1 RCT and 12 NRSIs). The studies were conducted worldwide; most originated from high-income countries (25 studies). Public institutions funded 22 (79%) of the studies. Most studies investigated the effects of rituximab on people with relapsing MS (19 studies; 27,500 (73%) participants). We identified 12 ongoing studies. Rituximab as 'first choice' for active relapsing MS None of the included studies compared rituximab to placebo. One RCT compared rituximab to dimethyl fumarate, with 24 months' follow-up. Rituximab may reduce the recurrence of relapse (odds ratio (OR) 0.16, 95% confidence interval (CI) 0.04 to 0.57; 195 participants; low-certainty evidence). The evidence is very uncertain on disability worsening and SAEs. Rituximab may result in little to no difference in upper respiratory tract infections (rate ratio (RR) 1.03, 95% CI 0.79 to 1.34; low-certainty evidence). The evidence is very uncertain for urinary tract, skin, and viral infections. HRQoL, cancer, and mortality were not reported. One NRSI compared rituximab to other DMTs, with 24 months' follow-up. Disability worsening was not reported. Compared with interferon beta or glatiramer acetate, rituximab likely delays relapse (hazard ratio (HR) 0.14, 95% CI 0.05 to 0.39; 1 study, 335 part","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD013874"},"PeriodicalIF":8.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11895426/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603753","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 : 2025-03-11DOI: 10.1002/14651858.CD014802.pub2
Linlin Fan, Jin Xu, Tao Wang, Kun Yang, Xuesong Bai, Wuyang Yang
<p><strong>Background: </strong>Large hemispheric infarction (LHI), caused by occlusion of the internal carotid or middle cerebral artery, is the most malignant type of supratentorial ischemic stroke. Due to severe intracranial edema, mortality fluctuates between 53% and 78%, even after the most effective medical treatment. Decompressive craniectomy can reduce mortality by approximately 17% to 36%, but the neurological outcomes are not satisfactory, and there are contraindications to surgery. Therapeutic hypothermia shows promising effects in preclinical research, but it causes many complications, and clinical studies have not confirmed its efficacy. Glibenclamide is a type of sulfonylurea. Preclinical research shows that glibenclamide can reduce mortality and brain edema and improve neurological outcomes in animal models of ischemic stroke. Sulfonylureas may be a promising treatment for individuals with LHI.</p><p><strong>Objectives: </strong>To evaluate the effects of sulfonylurea drugs in people with large hemispheric ischemic stroke.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, five other databases, and three trials registers. We also searched gray literature sources, checked the bibliographies of included studies and relevant systematic reviews, and used Cited Reference Search in Google Scholar. The latest search date was 23 March 2024.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials (RCTs) that compared sulfonylureas with placebo, hypothermia, or usual care in people with severe hemispheric ischemic stroke.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods. Our primary outcomes were neurological and functional outcomes. Our secondary outcomes were death, quality of life, adverse events, and complications. We used GRADE to assess the certainty of the evidence for each outcome.</p><p><strong>Main results: </strong>This review includes two RCTs (N = 621): the GAMES-RP trial (glyburide advantage in malignant edema and stroke) and the CHARM trial (phase 3 study to evaluate the efficacy and safety of intravenous BIIB093 (glibenclamide) for severe cerebral edema following large hemispheric infarction). Both studies compared the effects of intravenous glyburide (0.13 mg bolus intravenous injection for the first 2 minutes, followed by an infusion of 0.16 mg/h for the first 6 hours and then 0.11 mg/h for the remaining 66 hours) to placebo. The GAMES-RP trial (N = 86) was conducted in 18 hospitals in the USA (mean age: intervention = 58 ± 11 years; control = 63 ± 9 years); the CHARM trial (N = 535) was conducted in 20 countries across North and South America and Eurasia (mean age: intervention = 60.5 ± 11.17 years; control = 61.6 ± 10.81 years). The overall risk of bias was high in both trials. Neither trial reported neurological outcomes. Compared with placebo, glyburide may result in little to no difference in functional outcomes, assessed with t
{"title":"Sulfonylurea drugs for people with severe hemispheric ischemic stroke.","authors":"Linlin Fan, Jin Xu, Tao Wang, Kun Yang, Xuesong Bai, Wuyang Yang","doi":"10.1002/14651858.CD014802.pub2","DOIUrl":"10.1002/14651858.CD014802.pub2","url":null,"abstract":"<p><strong>Background: </strong>Large hemispheric infarction (LHI), caused by occlusion of the internal carotid or middle cerebral artery, is the most malignant type of supratentorial ischemic stroke. Due to severe intracranial edema, mortality fluctuates between 53% and 78%, even after the most effective medical treatment. Decompressive craniectomy can reduce mortality by approximately 17% to 36%, but the neurological outcomes are not satisfactory, and there are contraindications to surgery. Therapeutic hypothermia shows promising effects in preclinical research, but it causes many complications, and clinical studies have not confirmed its efficacy. Glibenclamide is a type of sulfonylurea. Preclinical research shows that glibenclamide can reduce mortality and brain edema and improve neurological outcomes in animal models of ischemic stroke. Sulfonylureas may be a promising treatment for individuals with LHI.</p><p><strong>Objectives: </strong>To evaluate the effects of sulfonylurea drugs in people with large hemispheric ischemic stroke.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, five other databases, and three trials registers. We also searched gray literature sources, checked the bibliographies of included studies and relevant systematic reviews, and used Cited Reference Search in Google Scholar. The latest search date was 23 March 2024.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials (RCTs) that compared sulfonylureas with placebo, hypothermia, or usual care in people with severe hemispheric ischemic stroke.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods. Our primary outcomes were neurological and functional outcomes. Our secondary outcomes were death, quality of life, adverse events, and complications. We used GRADE to assess the certainty of the evidence for each outcome.</p><p><strong>Main results: </strong>This review includes two RCTs (N = 621): the GAMES-RP trial (glyburide advantage in malignant edema and stroke) and the CHARM trial (phase 3 study to evaluate the efficacy and safety of intravenous BIIB093 (glibenclamide) for severe cerebral edema following large hemispheric infarction). Both studies compared the effects of intravenous glyburide (0.13 mg bolus intravenous injection for the first 2 minutes, followed by an infusion of 0.16 mg/h for the first 6 hours and then 0.11 mg/h for the remaining 66 hours) to placebo. The GAMES-RP trial (N = 86) was conducted in 18 hospitals in the USA (mean age: intervention = 58 ± 11 years; control = 63 ± 9 years); the CHARM trial (N = 535) was conducted in 20 countries across North and South America and Eurasia (mean age: intervention = 60.5 ± 11.17 years; control = 61.6 ± 10.81 years). The overall risk of bias was high in both trials. Neither trial reported neurological outcomes. Compared with placebo, glyburide may result in little to no difference in functional outcomes, assessed with t","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD014802"},"PeriodicalIF":8.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11895423/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603756","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 : 2025-03-11DOI: 10.1002/14651858.CD015127.pub2
Esther King, Delia Horn, Nina Gluchowski, Deirdre O'Reilly, Matteo Bruschettini, Chris Cooper, Roger F Soll
<p><strong>Background: </strong>Although physiological reflux is seen in nearly all newborns to varying degrees, symptoms can be severe and cause gastroesophageal reflux disease (GERD). In preterm infants, one symptom that is often attributed to GERD is apnea and associated cardiorespiratory events, such as bradycardia and oxygen desaturation. Although the relationship between GERD and apnea, bradycardia, and desaturation events remains a subject of ongoing investigation, trials of agents that reduce gastric acidity, such as proton pump inhibitors (PPI), have been conducted to assess the effect of these agents on GERD.</p><p><strong>Objectives: </strong>To assess the benefits and harms of PPIs for the treatment of preterm infants with diagnosed or suspected GERD.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, two trial registries, and Epistemonikos in October 2023. We checked reference lists of included studies, and studies and systematic reviews in which the subject matter was related to the intervention or population examined in this review.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials, quasi-randomized controlled trials, cross-over trials, and cluster-randomized trials that assessed the use of PPIs (including esomeprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole) alone or in combination. Infants had to receive treatment for a minimum of three days. We considered the following comparisons: (1) PPIs versus no treatment, (2) PPI versus positioning changes (elevated head of bed or prone positioning), (3) PPI versus dietary changes (thickened feeds). We excluded studies examining alginates and histamine receptor blockers. Studies including other non-pharmacological interventions for GERD were included if these interventions were available to infants in all study groups.</p><p><strong>Data collection and analysis: </strong>Two review authors independently identified eligible trials, reviewed the methodological quality of each trial, and extracted data on prespecified outcomes. Data were compared and differences resolved. We used standard methods of Cochrane Neonatal to synthesize data using relative risk (RR), risk difference (RD), and mean difference (MD).</p><p><strong>Main results: </strong>After screening 1217 articles, only two studies, enrolling a total of 62 infants, met our criteria. Both studies compared the use of PPIs to no treatment (placebo). One study included ten infants with a mean gestational age of 36.1 ± 0.7 weeks, who were treated with seven days of PPI or placebo, and then crossed over to the other study arm for seven days, with gastric pH monitoring performed at the end of each week. The other study included 52 infants with a mean gestational age of 31 weeks, who were randomized to a PPI or placebo for 14 days, with various outcomes measured at baseline and after 14 days. Both studies were judged to be at low risk of bias. Only one study (N = 52
{"title":"Safety and efficacy of proton pump inhibitors in preterm infants with gastroesophageal reflux disease.","authors":"Esther King, Delia Horn, Nina Gluchowski, Deirdre O'Reilly, Matteo Bruschettini, Chris Cooper, Roger F Soll","doi":"10.1002/14651858.CD015127.pub2","DOIUrl":"10.1002/14651858.CD015127.pub2","url":null,"abstract":"<p><strong>Background: </strong>Although physiological reflux is seen in nearly all newborns to varying degrees, symptoms can be severe and cause gastroesophageal reflux disease (GERD). In preterm infants, one symptom that is often attributed to GERD is apnea and associated cardiorespiratory events, such as bradycardia and oxygen desaturation. Although the relationship between GERD and apnea, bradycardia, and desaturation events remains a subject of ongoing investigation, trials of agents that reduce gastric acidity, such as proton pump inhibitors (PPI), have been conducted to assess the effect of these agents on GERD.</p><p><strong>Objectives: </strong>To assess the benefits and harms of PPIs for the treatment of preterm infants with diagnosed or suspected GERD.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, two trial registries, and Epistemonikos in October 2023. We checked reference lists of included studies, and studies and systematic reviews in which the subject matter was related to the intervention or population examined in this review.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials, quasi-randomized controlled trials, cross-over trials, and cluster-randomized trials that assessed the use of PPIs (including esomeprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole) alone or in combination. Infants had to receive treatment for a minimum of three days. We considered the following comparisons: (1) PPIs versus no treatment, (2) PPI versus positioning changes (elevated head of bed or prone positioning), (3) PPI versus dietary changes (thickened feeds). We excluded studies examining alginates and histamine receptor blockers. Studies including other non-pharmacological interventions for GERD were included if these interventions were available to infants in all study groups.</p><p><strong>Data collection and analysis: </strong>Two review authors independently identified eligible trials, reviewed the methodological quality of each trial, and extracted data on prespecified outcomes. Data were compared and differences resolved. We used standard methods of Cochrane Neonatal to synthesize data using relative risk (RR), risk difference (RD), and mean difference (MD).</p><p><strong>Main results: </strong>After screening 1217 articles, only two studies, enrolling a total of 62 infants, met our criteria. Both studies compared the use of PPIs to no treatment (placebo). One study included ten infants with a mean gestational age of 36.1 ± 0.7 weeks, who were treated with seven days of PPI or placebo, and then crossed over to the other study arm for seven days, with gastric pH monitoring performed at the end of each week. The other study included 52 infants with a mean gestational age of 31 weeks, who were randomized to a PPI or placebo for 14 days, with various outcomes measured at baseline and after 14 days. Both studies were judged to be at low risk of bias. Only one study (N = 52","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD015127"},"PeriodicalIF":8.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11895421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603754","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 : 2025-03-10DOI: 10.1002/14651858.CD001703.pub4
Michael C Ferraro, Donna M Urquhart, Giovanni E Ferreira, Michael A Wewege, Christina Abdel Shaheed, Adrian C Traeger, Jan L Hoving, Eric J Visser, James H McAuley, Aidan G Cashin
<p><strong>Background: </strong>Antidepressants are commonly used to treat low back pain and spine-related leg pain. However, their benefits and harms are uncertain. This is an update of a 2008 Cochrane review of antidepressants for non-specific low back pain.</p><p><strong>Objectives: </strong>To assess the benefits and harms of antidepressants for non-specific low back pain and spine-related leg pain.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform, and EU Clinical Trials Register from inception to 14 November 2024.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials that compared antidepressants with placebo, usual care, or no treatment/waiting list. Participants were 18 years of age or older with non-specific low back pain or spine-related leg pain of any duration. We excluded participants with low back pain due to spinal fracture, inflammatory disease, aortic dissection, malignancy, or infection. Primary outcomes were pain intensity and disability, measured at short-term follow-up (> 4 to 14 weeks post-randomisation), and total adverse events. Secondary outcomes were serious adverse events, withdrawals due to adverse events, depressive symptoms, and health-related quality of life.</p><p><strong>Data collection and analysis: </strong>Two review authors independently screened records to determine study inclusion, extracted data, and evaluated risk of bias using RoB 1 tool. Where possible, we conducted meta-analyses. We used GRADE to assess the certainty of evidence.</p><p><strong>Main results: </strong>We included 26 randomised controlled trials. Eighteen studies included 2535 participants with non-specific low back pain, seven studies included 329 participants with spine-related leg pain, and one study included 68 participants with either condition. Most participants had pain lasting more than three months, with a mean duration between 18 months and 20 years. Mean ages ranged from 27 to 59 years. Studies evaluated serotonin and norepinephrine reuptake inhibitors (SNRIs; eight studies), selective serotonin reuptake inhibitors (SSRIs; two studies), tricyclic antidepressants (TCAs; 14 studies), tetracyclic antidepressants (TeCAs; two studies), or 'other antidepressants' (two studies). All studies were placebo-controlled. Outcomes were measured at short-term follow-up in 73% of studies. All included studies had at least one domain judged at high risk of bias, with 69% at high risk of attrition bias. Non-specific low back pain (benefits) Moderate-certainty evidence demonstrated that SNRIs probably have a small effect on pain intensity (mean difference (MD) (0 to 100 scale) -5.25, 95% confidence interval (CI) -7.17 to -3.34; I<sup>2</sup> = 0; 4 studies, 1415 participants) and a trivial effect on disability (MD (0 to 24 scale) -0.91, 95% CI -1.
89；5项研究，1510名参与者；极低确定性证据）。目前尚不清楚 TCAs 是否会增加不良事件（RR 1.76，95% CI 0.79 至 3.90；7 项研究，474 名参与者；低确定性证据）或严重不良事件（Peto OR 6.64，95% CI 0.41 至 106.72；I² = 0%；1 项研究，142 名参与者；极低确定性证据）的风险。目前尚不清楚 SSRIs（RR 1.83，95% CI 0.14 至 24.19；I² = 95%；2 项研究，107 名参与者；极低确定性证据）或 TeCAs 是否会增加不良事件风险（RR 0.93，95% CI 0.79 至 1.09；1 项研究，52 名参与者；极低确定性证据）。没有研究评估了这些类别药物的严重不良事件风险。没有研究测量了其他抗抑郁药的不良事件总量。目前尚不清楚其他抗抑郁药是否会增加严重不良事件的风险（Peto OR 0.90，95% CI 0.16～4.96；1 项研究，42 名参与者；极低确定性证据）：我们发现，对于非特异性腰背痛患者，SNRIs 对疼痛强度的影响可能较小，对残疾的影响微乎其微，而且可能与不良反应有关。三氯乙酸类药物可能不会减轻腰背痛的强度，但可能对残疾程度有轻微影响。抗抑郁药对脊柱相关腿痛的影响尚不确定，但在未来的研究中，SNRIs 和 TCAs 可优先于其他类药物。SSRIs、TCAs、TeCAs 和其他抗抑郁药物对非特异性腰痛和脊柱相关腿痛的安全性证据仍不明确。
{"title":"Antidepressants for low back pain and spine-related leg pain.","authors":"Michael C Ferraro, Donna M Urquhart, Giovanni E Ferreira, Michael A Wewege, Christina Abdel Shaheed, Adrian C Traeger, Jan L Hoving, Eric J Visser, James H McAuley, Aidan G Cashin","doi":"10.1002/14651858.CD001703.pub4","DOIUrl":"10.1002/14651858.CD001703.pub4","url":null,"abstract":"<p><strong>Background: </strong>Antidepressants are commonly used to treat low back pain and spine-related leg pain. However, their benefits and harms are uncertain. This is an update of a 2008 Cochrane review of antidepressants for non-specific low back pain.</p><p><strong>Objectives: </strong>To assess the benefits and harms of antidepressants for non-specific low back pain and spine-related leg pain.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform, and EU Clinical Trials Register from inception to 14 November 2024.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials that compared antidepressants with placebo, usual care, or no treatment/waiting list. Participants were 18 years of age or older with non-specific low back pain or spine-related leg pain of any duration. We excluded participants with low back pain due to spinal fracture, inflammatory disease, aortic dissection, malignancy, or infection. Primary outcomes were pain intensity and disability, measured at short-term follow-up (> 4 to 14 weeks post-randomisation), and total adverse events. Secondary outcomes were serious adverse events, withdrawals due to adverse events, depressive symptoms, and health-related quality of life.</p><p><strong>Data collection and analysis: </strong>Two review authors independently screened records to determine study inclusion, extracted data, and evaluated risk of bias using RoB 1 tool. Where possible, we conducted meta-analyses. We used GRADE to assess the certainty of evidence.</p><p><strong>Main results: </strong>We included 26 randomised controlled trials. Eighteen studies included 2535 participants with non-specific low back pain, seven studies included 329 participants with spine-related leg pain, and one study included 68 participants with either condition. Most participants had pain lasting more than three months, with a mean duration between 18 months and 20 years. Mean ages ranged from 27 to 59 years. Studies evaluated serotonin and norepinephrine reuptake inhibitors (SNRIs; eight studies), selective serotonin reuptake inhibitors (SSRIs; two studies), tricyclic antidepressants (TCAs; 14 studies), tetracyclic antidepressants (TeCAs; two studies), or 'other antidepressants' (two studies). All studies were placebo-controlled. Outcomes were measured at short-term follow-up in 73% of studies. All included studies had at least one domain judged at high risk of bias, with 69% at high risk of attrition bias. Non-specific low back pain (benefits) Moderate-certainty evidence demonstrated that SNRIs probably have a small effect on pain intensity (mean difference (MD) (0 to 100 scale) -5.25, 95% confidence interval (CI) -7.17 to -3.34; I<sup>2</sup> = 0; 4 studies, 1415 participants) and a trivial effect on disability (MD (0 to 24 scale) -0.91, 95% CI -1.","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD001703"},"PeriodicalIF":8.8,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11890917/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143585009","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 : 2025-03-07DOI: 10.1002/14651858.CD003477.pub5
Jenny T van der Steen, Johannes C van der Wouden, Abigail M Methley, Hanneke J A Smaling, Annemieke C Vink, Manon S Bruinsma
<p><strong>Background: </strong>Dementia is a clinical syndrome with a number of different causes. It is characterised by deterioration in cognitive, behavioural, social and emotional functioning. Pharmacological interventions are available but have limited effect on many of the syndrome's features. However, receptivity to music may remain until the late phases of dementia, and music-based therapeutic interventions (which include, but are not limited to, music therapy) are suitable for people with advanced dementia. As there is uncertainty about the effectiveness of music-based therapeutic interventions, trials are being conducted to evaluate this. This review updates one last published in 2018 and examines the current evidence for the effects of music-based interventions for people with dementia.</p><p><strong>Objectives: </strong>To assess the effects of music-based therapeutic interventions for people with dementia on emotional well-being (including quality of life), mood disturbance or negative affect (i.e. depressive symptoms and anxiety), behavioural problems (i.e. overall behavioural problems or neuropsychiatric symptoms, and more specifically agitation or aggression), social behaviour and cognition, at the end of therapy and four or more weeks after the end of treatment, and to assess any adverse effects.</p><p><strong>Search methods: </strong>We searched the Cochrane Dementia and Cognitive Improvement Group's Specialised Register, MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (ISI Web of Science), LILACS (BIREME), ClinicalTrials.gov and the World Health Organisation's meta-register-the International Clinical Trials Registry Platform on 30 November 2023.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials of music-based therapeutic interventions (of at least five sessions) for people with dementia that measured any of our outcomes of interest. Control groups either received usual care or other activities with or without music.</p><p><strong>Data collection and analysis: </strong>Two review authors worked independently to screen the retrieved studies against the inclusion criteria and then to extract data from included studies and assess their risk of bias. If necessary, we contacted trial authors to ask for additional data, such as relevant subscales. We pooled data using the random-effects model. We assessed the certainty of the evidence for our two comparisons and our main outcomes of interest using GRADE.</p><p><strong>Main results: </strong>We included 30 studies with 1720 randomised participants that were conducted in 15 countries. Twenty-eight studies with 1366 participants contributed data to meta-analyses. Ten studies contributed data to long-term outcomes. Participants had dementia of varying degrees of severity and resided in institutions in most of the studies. Seven studies delivered an individual intervention; the other studies deliv
{"title":"Music-based therapeutic interventions for people with dementia.","authors":"Jenny T van der Steen, Johannes C van der Wouden, Abigail M Methley, Hanneke J A Smaling, Annemieke C Vink, Manon S Bruinsma","doi":"10.1002/14651858.CD003477.pub5","DOIUrl":"10.1002/14651858.CD003477.pub5","url":null,"abstract":"<p><strong>Background: </strong>Dementia is a clinical syndrome with a number of different causes. It is characterised by deterioration in cognitive, behavioural, social and emotional functioning. Pharmacological interventions are available but have limited effect on many of the syndrome's features. However, receptivity to music may remain until the late phases of dementia, and music-based therapeutic interventions (which include, but are not limited to, music therapy) are suitable for people with advanced dementia. As there is uncertainty about the effectiveness of music-based therapeutic interventions, trials are being conducted to evaluate this. This review updates one last published in 2018 and examines the current evidence for the effects of music-based interventions for people with dementia.</p><p><strong>Objectives: </strong>To assess the effects of music-based therapeutic interventions for people with dementia on emotional well-being (including quality of life), mood disturbance or negative affect (i.e. depressive symptoms and anxiety), behavioural problems (i.e. overall behavioural problems or neuropsychiatric symptoms, and more specifically agitation or aggression), social behaviour and cognition, at the end of therapy and four or more weeks after the end of treatment, and to assess any adverse effects.</p><p><strong>Search methods: </strong>We searched the Cochrane Dementia and Cognitive Improvement Group's Specialised Register, MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (ISI Web of Science), LILACS (BIREME), ClinicalTrials.gov and the World Health Organisation's meta-register-the International Clinical Trials Registry Platform on 30 November 2023.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials of music-based therapeutic interventions (of at least five sessions) for people with dementia that measured any of our outcomes of interest. Control groups either received usual care or other activities with or without music.</p><p><strong>Data collection and analysis: </strong>Two review authors worked independently to screen the retrieved studies against the inclusion criteria and then to extract data from included studies and assess their risk of bias. If necessary, we contacted trial authors to ask for additional data, such as relevant subscales. We pooled data using the random-effects model. We assessed the certainty of the evidence for our two comparisons and our main outcomes of interest using GRADE.</p><p><strong>Main results: </strong>We included 30 studies with 1720 randomised participants that were conducted in 15 countries. Twenty-eight studies with 1366 participants contributed data to meta-analyses. Ten studies contributed data to long-term outcomes. Participants had dementia of varying degrees of severity and resided in institutions in most of the studies. Seven studies delivered an individual intervention; the other studies deliv","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD003477"},"PeriodicalIF":8.8,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11884930/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572365","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 : 2025-03-07DOI: 10.1002/14651858.CD015083.pub2
Sean Docking, Shivadharshini Sridhar, Romi Haas, Kevin Mao, Helen Ramsay, Rachelle Buchbinder, Denise O'Connor
<p><strong>Background: </strong>Alternative care models seek to improve the quality or efficiency of care, or both, and thus optimise patient health outcomes. They provide the same health care but change how, when, where, or by whom health care is delivered and co-ordinated. Examples include care delivered via telemedicine versus in-person care or care delivered to groups versus individual patients.</p><p><strong>Objectives: </strong>To assess the effects of alternative models of evidenced-based care for people with non-specific low back pain on the quality of care and patient self-reported outcomes and to summarise the availability and principal findings of economic evaluations of these alternative models.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and trial registries up to 14 June 2024, unrestricted by language.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials comparing alternative care models to usual care or other care models. Eligible trials had to investigate care models that changed at least one domain of the Cochrane EPOC delivery arrangement taxonomy and provide the same care as the comparator arm. Participants were individuals with non-specific low back pain, regardless of symptom duration. Main outcomes were quality of care (referral for/receipt of lumbar spine imaging, prescription/use of opioids, referral to a surgeon/lumbar spine surgery, admission to hospital for back pain), patient health outcomes (pain, back-related function), and adverse events.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies for inclusion, extracted data, and assessed risk of bias and the certainty of evidence using GRADE. The primary comparison was alternative models of care versus usual care at closest follow-up to 12 months.</p><p><strong>Main results: </strong>Fifty-seven trials (29,578 participants) met our inclusion criteria. Trials were primarily set within primary care (18 trials) or physiotherapy practices (15 trials) in high-income countries (51 trials). Forty-eight trials compared alternative models of care to usual care. There was substantial clinical diversity across alternative care models. Alternative care models most commonly differed from usual care by altering the co-ordination/management of care processes (18 trials), or by utilising information and communication technology (10 trials). Moderate-certainty evidence indicates that alternative care models probably result in little difference in referral for or receipt of any lumbar spine imaging at follow-up closest to 12 months compared to usual care (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.86 to 0.98; I<sup>2</sup> = 2%; 18 trials, 16,157 participants). In usual care, 232/1000 people received lumbar spine imaging compared to 213/1000 people who received alternative care models. We downgraded the certainty
{"title":"Models of care for managing non-specific low back pain.","authors":"Sean Docking, Shivadharshini Sridhar, Romi Haas, Kevin Mao, Helen Ramsay, Rachelle Buchbinder, Denise O'Connor","doi":"10.1002/14651858.CD015083.pub2","DOIUrl":"10.1002/14651858.CD015083.pub2","url":null,"abstract":"<p><strong>Background: </strong>Alternative care models seek to improve the quality or efficiency of care, or both, and thus optimise patient health outcomes. They provide the same health care but change how, when, where, or by whom health care is delivered and co-ordinated. Examples include care delivered via telemedicine versus in-person care or care delivered to groups versus individual patients.</p><p><strong>Objectives: </strong>To assess the effects of alternative models of evidenced-based care for people with non-specific low back pain on the quality of care and patient self-reported outcomes and to summarise the availability and principal findings of economic evaluations of these alternative models.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and trial registries up to 14 June 2024, unrestricted by language.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials comparing alternative care models to usual care or other care models. Eligible trials had to investigate care models that changed at least one domain of the Cochrane EPOC delivery arrangement taxonomy and provide the same care as the comparator arm. Participants were individuals with non-specific low back pain, regardless of symptom duration. Main outcomes were quality of care (referral for/receipt of lumbar spine imaging, prescription/use of opioids, referral to a surgeon/lumbar spine surgery, admission to hospital for back pain), patient health outcomes (pain, back-related function), and adverse events.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies for inclusion, extracted data, and assessed risk of bias and the certainty of evidence using GRADE. The primary comparison was alternative models of care versus usual care at closest follow-up to 12 months.</p><p><strong>Main results: </strong>Fifty-seven trials (29,578 participants) met our inclusion criteria. Trials were primarily set within primary care (18 trials) or physiotherapy practices (15 trials) in high-income countries (51 trials). Forty-eight trials compared alternative models of care to usual care. There was substantial clinical diversity across alternative care models. Alternative care models most commonly differed from usual care by altering the co-ordination/management of care processes (18 trials), or by utilising information and communication technology (10 trials). Moderate-certainty evidence indicates that alternative care models probably result in little difference in referral for or receipt of any lumbar spine imaging at follow-up closest to 12 months compared to usual care (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.86 to 0.98; I<sup>2</sup> = 2%; 18 trials, 16,157 participants). In usual care, 232/1000 people received lumbar spine imaging compared to 213/1000 people who received alternative care models. We downgraded the certainty ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD015083"},"PeriodicalIF":8.8,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11887030/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572356","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 : 2025-03-06DOI: 10.1002/14651858.CD010001.pub4
Rosa B Gutarra-Vilchez, Juan C Vazquez, Demián Glujovsky, Frank Lizaraso, Andres Viteri-García, Maria José Martinez-Zapata
<p><strong>Background: </strong>The rate of successful pregnancies brought to term has barely increased since the first assisted reproductive technology (ART) technique became available. Research suggests that vasodilators may increase endometrial receptivity, thicken the endometrium, and favour uterine relaxation, all of which could improve the chances of successful assisted pregnancy.</p><p><strong>Objectives: </strong>To evaluate the effectiveness and safety of vasodilators in women undergoing fertility treatment.</p><p><strong>Search methods: </strong>We searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL, MEDLINE, Embase, three other databases, and two clinical trial registries in April 2024, with no language or date restrictions. We also searched grey literature sources and checked the reference lists of relevant articles.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing vasodilators (alone or combined with other treatments) versus placebo or no treatment or versus other agents in women undergoing fertility treatment.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies, assessed risk of bias, extracted data, and calculated risk ratios (RRs). We combined study data using a fixed-effect model and assessed evidence certainty using the GRADE approach. Our primary outcomes were live birth or ongoing pregnancy and vasodilator side effects. Our secondary outcomes were clinical pregnancy, endometrial thickness, multiple gestation, miscarriage, and ectopic pregnancy.</p><p><strong>Main results: </strong>We included 45 studies with a total of 4404 women. The included studies compared a vasodilator versus a placebo or no treatment (40 RCTs), vasodilators plus another agent versus placebo or no treatment (3 RCTs) or versus oestrogens (3 RCTs). The mean length of follow-up was 15.45 weeks. Overall, the certainty of evidence was very low to moderate. The main limitations were imprecision (low number of events and participants) and risk of bias (lack of blinding in studies that reported subjective outcomes). Vasodilators versus placebo or no treatment Vasodilators may result in little to no difference in rates of live birth or ongoing pregnancy compared with placebo or no treatment (RR 1.21, 95% CI 0.93 to 1.58; I² = 0%; 6 RCTs, 740 women; low-certainty evidence), but probably increase overall rates of side effects (RR 2.14, 95% CI 1.55 to 2.98; I² = 0%; 7 RCTs, 668 women; moderate-certainty evidence). The evidence suggests that 246 per 1000 women achieve live birth or ongoing pregnancy with a placebo or no treatment, and 229 to 389 per 1000 will do so using vasodilators. Vasodilators compared with placebo or no treatment likely increase rates of clinical pregnancy (RR 1.45, 95% CI 1.28 to 1.64; I² = 22%; 25 RCTs, 2506 women; moderate-certainty evidence). Vasodilators compared with placebo or no treatm
{"title":"Vasodilators for women undergoing fertility treatment.","authors":"Rosa B Gutarra-Vilchez, Juan C Vazquez, Demián Glujovsky, Frank Lizaraso, Andres Viteri-García, Maria José Martinez-Zapata","doi":"10.1002/14651858.CD010001.pub4","DOIUrl":"10.1002/14651858.CD010001.pub4","url":null,"abstract":"<p><strong>Background: </strong>The rate of successful pregnancies brought to term has barely increased since the first assisted reproductive technology (ART) technique became available. Research suggests that vasodilators may increase endometrial receptivity, thicken the endometrium, and favour uterine relaxation, all of which could improve the chances of successful assisted pregnancy.</p><p><strong>Objectives: </strong>To evaluate the effectiveness and safety of vasodilators in women undergoing fertility treatment.</p><p><strong>Search methods: </strong>We searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL, MEDLINE, Embase, three other databases, and two clinical trial registries in April 2024, with no language or date restrictions. We also searched grey literature sources and checked the reference lists of relevant articles.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing vasodilators (alone or combined with other treatments) versus placebo or no treatment or versus other agents in women undergoing fertility treatment.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies, assessed risk of bias, extracted data, and calculated risk ratios (RRs). We combined study data using a fixed-effect model and assessed evidence certainty using the GRADE approach. Our primary outcomes were live birth or ongoing pregnancy and vasodilator side effects. Our secondary outcomes were clinical pregnancy, endometrial thickness, multiple gestation, miscarriage, and ectopic pregnancy.</p><p><strong>Main results: </strong>We included 45 studies with a total of 4404 women. The included studies compared a vasodilator versus a placebo or no treatment (40 RCTs), vasodilators plus another agent versus placebo or no treatment (3 RCTs) or versus oestrogens (3 RCTs). The mean length of follow-up was 15.45 weeks. Overall, the certainty of evidence was very low to moderate. The main limitations were imprecision (low number of events and participants) and risk of bias (lack of blinding in studies that reported subjective outcomes). Vasodilators versus placebo or no treatment Vasodilators may result in little to no difference in rates of live birth or ongoing pregnancy compared with placebo or no treatment (RR 1.21, 95% CI 0.93 to 1.58; I² = 0%; 6 RCTs, 740 women; low-certainty evidence), but probably increase overall rates of side effects (RR 2.14, 95% CI 1.55 to 2.98; I² = 0%; 7 RCTs, 668 women; moderate-certainty evidence). The evidence suggests that 246 per 1000 women achieve live birth or ongoing pregnancy with a placebo or no treatment, and 229 to 389 per 1000 will do so using vasodilators. Vasodilators compared with placebo or no treatment likely increase rates of clinical pregnancy (RR 1.45, 95% CI 1.28 to 1.64; I² = 22%; 25 RCTs, 2506 women; moderate-certainty evidence). Vasodilators compared with placebo or no treatm","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD010001"},"PeriodicalIF":8.8,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883854/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566269","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 : 2025-03-04DOI: 10.1002/14651858.CD016085
Lucia B Varela, Samanta Díaz Menai, Camila Micaela Escobar Liquitay, Mariana Andrea Burgos, Diego Ivaldi, Luis Garegnani
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of intensive systolic blood pressure management (target less than 160 mmHg) versus conventional management (target less than 180 mmHg) in people undergoing ischemic stroke reperfusion via systemic thrombolysis or endovascular thrombectomy.
{"title":"Blood pressure management in reperfused ischemic stroke.","authors":"Lucia B Varela, Samanta Díaz Menai, Camila Micaela Escobar Liquitay, Mariana Andrea Burgos, Diego Ivaldi, Luis Garegnani","doi":"10.1002/14651858.CD016085","DOIUrl":"10.1002/14651858.CD016085","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of intensive systolic blood pressure management (target less than 160 mmHg) versus conventional management (target less than 180 mmHg) in people undergoing ischemic stroke reperfusion via systemic thrombolysis or endovascular thrombectomy.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD016085"},"PeriodicalIF":8.8,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11877636/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540302","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 : 2025-03-04DOI: 10.1002/14651858.CD016020
Teresa Isabel Calheiros Cruz Vidigal, Yolanda Rando Matos, Gemma Flores Mateo, José Luis Ballvé Moreno, Eva Peguero Rodríguez
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of the Epley maneuver, performed by family doctors or emergency physicians, for adults with benign paroxysmal positional vertigo.
{"title":"Epley maneuver, performed by family doctors or emergency physicians, for benign paroxysmal positional vertigo in adults.","authors":"Teresa Isabel Calheiros Cruz Vidigal, Yolanda Rando Matos, Gemma Flores Mateo, José Luis Ballvé Moreno, Eva Peguero Rodríguez","doi":"10.1002/14651858.CD016020","DOIUrl":"10.1002/14651858.CD016020","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of the Epley maneuver, performed by family doctors or emergency physicians, for adults with benign paroxysmal positional vertigo.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD016020"},"PeriodicalIF":8.8,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11877634/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540317","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 : 2025-03-03DOI: 10.1002/14651858.CD007310.pub3
Tesfaye H Tufa, Fiona Stewart, Karen Meckstroth, Justin T Diedrich, Sara J Newmann
<p><strong>Background: </strong>Abortion is a common procedure. Complications associated with abortion increase as gestational age increases. Cervical preparation is recommended prior to second trimester surgical abortion. Evidence is lacking as to the most effective methods of cervical preparation.</p><p><strong>Objectives: </strong>To assess the effectiveness of cervical preparation methods for people undergoing second trimester surgical abortion at gestational age between 12 and 24 0/7 weeks.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE ALL, Embase.com, Global Index Medicus, Scopus, and Google Scholar on 20 December 2021. We also searched reference lists, review articles, books, and conference proceedings. We contacted experts for information on other published or unpublished research. The COVID-19 pandemic greatly disrupted the writing and publication of this review; the search is outdated, but an updated search will be performed prior to the next update.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials (RCTs) investigating any cervical preparation method for second trimester surgical abortion from 12 to 24 weeks gestation.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods.</p><p><strong>Main results: </strong>We identified 21 RCTs (3029 participants). Some trials were at high risk of detection and reporting bias. Prostaglandin versus osmotic dilators (4 studies, 373 participants; 12 6/7 to 20 weeks) Prostaglandin may result in little to no difference in ability to complete procedure (risk ratio [RR] 0.99, 95% confidence interval [CI] 0.95 to 1.03; low-certainty evidence), but probably leads to less dilation achieved (mean difference [MD] -3.58 mm, 95% CI -4.58 to -2.58; moderate-certainty evidence) when compared to osmotic dilators. Mifepristone plus 400 μg buccal misoprostol versus osmotic dilators (1 study, 49 participants; 15 0/7 to 18 0/7 weeks) Mifepristone plus misoprostol may have little to no effect on ability to complete procedure (RR 1.00, 95% CI 0.92 to 1.08; low-certainty evidence) and procedure time (MD -0.30, 95% CI -3.46 to 2.86) when compared to osmotic dilators. The combination may lead to less dilation achieved (MD -1.67 mm, 95% CI -3.19 to -0.15; low-certainty evidence) and increased need for additional dilation (RR 1.92, 95% CI 1.16 to 3.18; low-certainty evidence) compared to osmotic dilators. 400 μg buccal misoprostol plus osmotic dilators versus placebo plus osmotic dilators (4 studies, 545 participants; 13 to 23 6/7 weeks) Misoprostol plus osmotic dilators probably has no effect on ability to complete procedure (RR 0.99, 95% CI 0.96 to 1.02; moderate-certainty evidence), but probably increases dilation achieved (MD 1.83 mm, 95% CI 0.27 to 3.39; moderate-certainty evidence) and reduces need for additional dilation (RR 0.65, 95% CI 0.50 to 0.84; moderate-certainty evidence) and procedure time (MD -0.99 min, 95% CI -2.05 to 0.0
{"title":"Cervical preparation for dilation and evacuation at 12 to 24 weeks gestation.","authors":"Tesfaye H Tufa, Fiona Stewart, Karen Meckstroth, Justin T Diedrich, Sara J Newmann","doi":"10.1002/14651858.CD007310.pub3","DOIUrl":"10.1002/14651858.CD007310.pub3","url":null,"abstract":"<p><strong>Background: </strong>Abortion is a common procedure. Complications associated with abortion increase as gestational age increases. Cervical preparation is recommended prior to second trimester surgical abortion. Evidence is lacking as to the most effective methods of cervical preparation.</p><p><strong>Objectives: </strong>To assess the effectiveness of cervical preparation methods for people undergoing second trimester surgical abortion at gestational age between 12 and 24 0/7 weeks.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE ALL, Embase.com, Global Index Medicus, Scopus, and Google Scholar on 20 December 2021. We also searched reference lists, review articles, books, and conference proceedings. We contacted experts for information on other published or unpublished research. The COVID-19 pandemic greatly disrupted the writing and publication of this review; the search is outdated, but an updated search will be performed prior to the next update.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials (RCTs) investigating any cervical preparation method for second trimester surgical abortion from 12 to 24 weeks gestation.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods.</p><p><strong>Main results: </strong>We identified 21 RCTs (3029 participants). Some trials were at high risk of detection and reporting bias. Prostaglandin versus osmotic dilators (4 studies, 373 participants; 12 6/7 to 20 weeks) Prostaglandin may result in little to no difference in ability to complete procedure (risk ratio [RR] 0.99, 95% confidence interval [CI] 0.95 to 1.03; low-certainty evidence), but probably leads to less dilation achieved (mean difference [MD] -3.58 mm, 95% CI -4.58 to -2.58; moderate-certainty evidence) when compared to osmotic dilators. Mifepristone plus 400 μg buccal misoprostol versus osmotic dilators (1 study, 49 participants; 15 0/7 to 18 0/7 weeks) Mifepristone plus misoprostol may have little to no effect on ability to complete procedure (RR 1.00, 95% CI 0.92 to 1.08; low-certainty evidence) and procedure time (MD -0.30, 95% CI -3.46 to 2.86) when compared to osmotic dilators. The combination may lead to less dilation achieved (MD -1.67 mm, 95% CI -3.19 to -0.15; low-certainty evidence) and increased need for additional dilation (RR 1.92, 95% CI 1.16 to 3.18; low-certainty evidence) compared to osmotic dilators. 400 μg buccal misoprostol plus osmotic dilators versus placebo plus osmotic dilators (4 studies, 545 participants; 13 to 23 6/7 weeks) Misoprostol plus osmotic dilators probably has no effect on ability to complete procedure (RR 0.99, 95% CI 0.96 to 1.02; moderate-certainty evidence), but probably increases dilation achieved (MD 1.83 mm, 95% CI 0.27 to 3.39; moderate-certainty evidence) and reduces need for additional dilation (RR 0.65, 95% CI 0.50 to 0.84; moderate-certainty evidence) and procedure time (MD -0.99 min, 95% CI -2.05 to 0.0","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD007310"},"PeriodicalIF":8.8,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11873992/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540313","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}
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