Cochrane Database of Systematic Reviews最新文献

{"title":"Parallel use of low-complexity automated nucleic acid amplification tests on respiratory and stool samples with or without lateral flow lipoarabinomannan assays to detect pulmonary tuberculosis disease in children.","authors":"Laura Olbrich, Bada Yang, Hayley Poore, Alia Razid, Brittney Sweetser, Mathias Weis Damkjær, Alexander W Kay, Johanna Åhsberg, Ruvandhi R Nathavitharana, Ian Schiller, Nandini Dendukuri, Andreas Lundh, Maunank Shah, Stephanie Bjerrum, Devan Jaganath","doi":"10.1002/14651858.CD016071.pub2","DOIUrl":"10.1002/14651858.CD016071.pub2","url":null,"abstract":"<p><strong>Background: </strong>Low-complexity automated nucleic acid amplification tests (LC-aNAATs) are molecular assays widely used to diagnose tuberculosis disease in children. The lateral flow urine lipoarabinomannan assay (LF-LAM) is recommended for use amongst children with HIV. Previous systematic reviews have assessed the diagnostic accuracy of LC-aNAATs and LF-LAM separately in children, but in clinical practice the tests may be used concurrently, i.e. in 'parallel'.</p><p><strong>Objectives: </strong>To compare the diagnostic accuracy of the parallel use of LC-aNAAT on respiratory and stool specimens in children, and with LF-LAM on urine amongst children with HIV, versus each assay alone for detecting pulmonary tuberculosis disease.</p><p><strong>Search methods: </strong>We searched MEDLINE, Embase, Science Citation Index-Expanded, Conference Proceedings Citation Index - Science, Biosis Previews, the Cochrane Central Register of Controlled Trials, Scopus, WHO (World Health Organization) Global Index Medicus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry up to 3 November 2023. There was a WHO public call for data on the accuracy of LC-aNAAT and LF-LAM for children until December 2023.</p><p><strong>Selection criteria: </strong>We included studies that enroled children under 10 years of age with presumptive pulmonary tuberculosis, and provided data to assess the accuracy of parallel testing and at least one of the component tests, against a microbiological reference standard (MRS) based on culture or composite reference standard (CRS) that included clinical diagnosis.</p><p><strong>Data collection and analysis: </strong>We extracted data using a standardised form and assessed study quality using QUADAS-2 and QUADAS-C tools. We performed bivariate random-effects meta-analysis using a Bayesian approach to estimate sensitivity and specificity and absolute differences between index tests. Diagnostic accuracy estimates were calculated primarily against the MRS and secondarily against the CRS. We used GRADE to assess the certainty of the evidence on comparative accuracy.</p><p><strong>Main results: </strong>We included 14 studies to assess parallel testing in children with and without HIV. In addition, six of the 14 studies were included to evaluate LC-aNAATs with LF-LAM amongst children with HIV. Other than a high risk of bias with the CRS due to the potential incorporation of index results in clinical diagnoses, studies generally had low risk of bias across QUADAS-2 and QUADAS-C domains. Parallel use of respiratory and stool LC-aNAATs Children without HIV or HIV status unknown We included eight studies (2145 participants, tuberculosis prevalence 8.1% (173/2145)) for assessment against the MRS. Parallel use of LC-aNAAT on respiratory samples and stool had an estimated pooled sensitivity of 79.9% (95% credible interval (CrI) 67.9 to 89.8) and an estimated pooled specificity of 93.4% (95% CrI 87.2 to 97.0). Compared to ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"6 ","pages":"CD016071"},"PeriodicalIF":8.8,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12153044/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265513","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}

{"title":"Progestogen for preventing miscarriage in women with recurrent miscarriage of unclear etiology.","authors":"David M Haas, Magdalena Bofill Rodriguez, Taylor J Hathaway, Patrick S Ramsey","doi":"10.1002/14651858.CD003511.pub6","DOIUrl":"10.1002/14651858.CD003511.pub6","url":null,"abstract":"<p><strong>Rationale: </strong>Progesterone, a female sex hormone, is known to induce secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. Miscarriage is an early pregnancy loss. For women who have recurrent miscarriage, it has been suggested that a causative factor may be inadequate secretion of progesterone. Therefore, clinicians sometimes use progestogens (drugs that interact with the progesterone receptors), beginning in the first trimester of pregnancy, in an attempt to prevent spontaneous miscarriage. It is important to understand if this is beneficial or harmful. This is an update of the review, last published in 2019. Previous versions included two trials that have since been retracted. This update included an updated trial search and evaluation of all trials using the Cochrane Trustworthiness Screening Tool.</p><p><strong>Objectives: </strong>To assess the benefits and harms of progestogens as a preventative therapy against recurrent miscarriage.</p><p><strong>Search methods: </strong>For this update, we searched CENTRAL, MEDLINE, Embase, CINAHL, Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (July 2024). We also searched reference lists from relevant articles, attempted to contact trial authors where necessary, and contacted experts in the field for unpublished works.</p><p><strong>Eligibility criteria: </strong>We included randomized or quasi-randomized controlled trials in pregnant participants comparing progestogens with placebo or no treatment, given in an effort to prevent miscarriage. We included trials of participants who were diagnosed with recurrent miscarriage (usually of unknown origin) and who began treatment with progestogens in the first trimester of pregnancy. We excluded trials treating participants with threatened miscarriage or who had conceived by in-vitro fertilization.</p><p><strong>Outcomes: </strong>The critical outcome was miscarriage. The main important outcomes were live birth rate and preterm birth (< 37 weeks' gestation). Other important outcomes were neonatal death, fetal genital abnormalities, stillbirth, low birthweight (< 2500 g), maternal adverse events and neonatal intensive care unit admission. Other maternal outcomes of interest were severity of 'morning sickness', thromboembolic events, depression, admission to special care unit and subsequent fertility.</p><p><strong>Risk of bias: </strong>Two review authors assessed the studies using the RoB 1 tool for selection, performance, detection, attrition, incomplete outcome data, selective reporting and other bias.</p><p><strong>Synthesis methods: </strong>Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two reviewers assessed the certainty of the evidence using the GRADE approach. We utilized a random-effects model to synthesize the results.</p","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"6 ","pages":"CD003511"},"PeriodicalIF":8.8,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12153038/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265514","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}

{"title":"Parallel use of low-complexity automated nucleic acid amplification tests and lateral flow urine lipoarabinomannan assays to detect tuberculosis disease in adults and adolescents living with HIV.","authors":"Stephanie Bjerrum, Bada Yang, Johanna Åhsberg, Laura Olbrich, Mathias Weis Damkjær, Ruvandhi R Nathavitharana, Tobias Broger, Ioana Diana Olaru, Brittney Sweetser, Hayley Poore, Alia Razid, Alexander W Kay, Claudia M Denkinger, Ian Schiller, Nandini Dendukuri, Devan Jaganath, Andreas Lundh, Maunank Shah","doi":"10.1002/14651858.CD016070.pub2","DOIUrl":"10.1002/14651858.CD016070.pub2","url":null,"abstract":"<p><strong>Background: </strong>Low-complexity automated nucleic acid amplification tests (LC-aNAATs) are molecular World Health Organization (WHO)-recommended rapid diagnostic tests (also known as mWRDs) widely used to diagnose tuberculosis disease. The lateral flow urine lipoarabinomannan assay (LF-LAM) is recommended by the WHO to assist in diagnosing tuberculosis disease amongst people with HIV. Previous systematic reviews have assessed the diagnostic accuracy of LC-aNAATs and LF-LAM used in isolation for the detection of tuberculosis, but in clinical practice the tests may be used in parallel (i.e. LC-aNAAT in combination with LF-LAM).</p><p><strong>Objectives: </strong>To compare the diagnostic accuracy of the parallel use of LC-aNAAT on respiratory samples and LF-LAM on urine versus LC-aNAATs on respiratory samples alone for detection of tuberculosis disease in adults and adolescents with HIV who present with presumptive tuberculosis.</p><p><strong>Search methods: </strong>We searched Cochrane CENTRAL, MEDLINE, Embase, Science Citation Index-Expanded, Biosis Previews, Conference Proceedings Citation Index - Science, Scopus, WHO Global Index Medicus, ProQuest Dissertations & Theses, ClinicalTrial.gov, and the WHO International Clinical Trials Registry up to 3 November 2023.</p><p><strong>Selection criteria: </strong>We included studies that allowed assessment of the diagnostic accuracy of parallel testing and LC-aNAAT on respiratory samples in the same study group. Participants were adults and adolescents (defined as 10 years of age and older) with HIV who presented with presumptive tuberculosis. The reference standards we used for the detection of tuberculosis disease were microbiological or composite. As well as published studies, we included unpublished data if the data provided by study authors on request were the final data and could be used to compare diagnostic accuracy of parallel testing to one of the component tests.</p><p><strong>Data collection and analysis: </strong>Two review authors independently extracted data using a standardised form and assessed methodological quality using QUADAS-2 and QUADAS-C tools. We performed bivariate random-effects meta-analysis using a Bayesian approach to estimate sensitivity, specificity, and absolute differences between index tests. We performed subgroup analyses based on the presence of signs and symptoms, CD4 cell count, and clinical setting, as well as separate analyses for those with a positive screen for tuberculosis, advanced HIV, or serious illness.</p><p><strong>Main results: </strong>In 27 studies involving 12,651 participants, of whom 2368 (19%) had tuberculosis based on a microbiological reference standard, the parallel use of respiratory LC-aNAAT and urine LF-LAM had a pooled sensitivity of 77.5% (95% credible interval (CrI) 73.4 to 81.3) and specificity of 89.4% (95% CrI 85.8 to 92.3). Compared to respiratory LC-aNAAT alone, parallel testing had 6.7 (95% CrI 3.8 to 10.7) percentag","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"6 ","pages":"CD016070"},"PeriodicalIF":8.8,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12150366/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144257476","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}

{"title":"Lymphadenectomy or sentinel node biopsy for the management of endometrial cancer.","authors":"Joanne Moffatt, Katie E Webster, Kerry Dwan, Jonathan A Frost, Jo Morrison","doi":"10.1002/14651858.CD015786.pub2","DOIUrl":"10.1002/14651858.CD015786.pub2","url":null,"abstract":"<p><strong>Rationale: </strong>Endometrial cancer, which affects the lining of the uterus, is the most common form of uterine cancer (96%), and the sixth most common cancer in females worldwide, accounting for 4.5% of all cancers in females. In 2022, there were 420,242 cases of uterine cancer and 97,704 deaths from the disease worldwide. Most women have early-stage endometrial cancer at diagnosis. Traditionally, surgical staging included removal of all lymph nodes (lymphadenectomy) in the pelvis (pelvic lymphadenectomy) with or without para-aortic areas (pelvic/para-aortic lymphadenectomy), to determine the need for further treatment. However, rates of lymph node involvement are relatively low and may be predicted by uterine histopathology and molecular markers. Lymphadenectomy carries a significant risk of long-term morbidity from lymphoedema and previous studies comparing pelvic lymphadenectomy with no lymphadenectomy found no survival benefit. Detecting the first draining lymph node(s) from each side of the uterus, called sentinel lymph node biopsy, can replace lymphadenectomy in terms of accuracy of detecting nodes, but no studies have shown whether sentinel lymph node biopsy is beneficial to women, despite its wide use.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of lymphadenectomy and sentinel lymph node biopsy for the management of endometrial cancer comparing different head-to-head comparisons in a network meta-analysis allowing ranking of treatment strategies.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov and the WHO ICTRP for studies up to 22 March 2024.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) of women with early-stage endometrial cancer, comparing combinations of no lymphadenectomy, pelvic lymphadenectomy, pelvic/para-aortic lymphadenectomy and sentinel lymph node biopsy. We excluded non-randomised studies and studies assessing diagnostic test accuracy of lymph node sampling.</p><p><strong>Outcomes: </strong>Overall survival; progression-free survival; morbidity and mortality related to surgery; early and late adverse events, including lymphoedema and lymphocyst formation; and quality of life.</p><p><strong>Risk of bias: </strong>We used RoB 2 to assess risk of bias.</p><p><strong>Synthesis methods: </strong>We conducted meta-analyses using random-effects models to calculate hazard ratios (HR) for time-to-event data and risk ratios (RR) and mean difference (MD) for other outcomes, with 95% confidence intervals (CI). We used GRADE to summarise the certainty of evidence. We intended to compare treatments in a network meta-analysis.</p><p><strong>Included studies: </strong>We included five RCTs (one remains ongoing) with 2074 women. Studies were conducted in the UK, South Africa, Poland, New Zealand, Chile, Italy, Egypt and Brazil, and published between 2008 and 2023. Another 10 studies are ongoing. Three studie","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"6 ","pages":"CD015786"},"PeriodicalIF":8.8,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12150361/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144257475","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}

{"title":"Stapler versus scalpel resection followed by handsewn closure of the pancreatic remnant for distal pancreatectomy.","authors":"Pascal Probst, Felix J Hüttner, Ulla Klaiber, Phillip Knebel, Alexis Ulrich, Markus W Büchler, Markus K Diener","doi":"10.1002/14651858.CD008688.pub3","DOIUrl":"10.1002/14651858.CD008688.pub3","url":null,"abstract":"<p><strong>Background: </strong>Resections of the pancreatic body and tail reaching to the left of the superior mesenteric vein are defined as distal pancreatectomy. Most distal pancreatectomies are elective treatments for chronic pancreatitis, benign or malignant diseases, and they have high morbidity rates of up to 40%. Pancreatic fistula formation is the main source of postoperative morbidity, and is associated with numerous further complications. Researchers have proposed several surgical resection and closure techniques of the pancreatic remnant in an attempt to reduce these complications. The two most common techniques are scalpel resection followed by handsewn closure of the pancreatic remnant and stapler resection and closure.</p><p><strong>Objectives: </strong>To assess the effects of stapler resection and closure compared to scalpel resection followed by handsewn closure of the pancreatic remnant in people undergoing distal pancreatectomy.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase from database inception to October 2023, and the ISGPS Evidence Map of Pancreatic Surgery to 9 April 2025.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing stapler versus scalpel resection followed by handsewn closure of the pancreatic remnant for open distal pancreatectomy (irrespective of language or publication status).</p><p><strong>Data collection and analysis: </strong>Two review authors independently assessed trials for inclusion and performed data extraction. Our outcomes of interest were postoperative mortality and morbidity, especially postoperative pancreatic fistula. Taking into account the clinical heterogeneity between trials (e.g. different endpoint definitions), we analysed data using a random-effects model in RevMan, calculating risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI). We used GRADE to assess the certainty of evidence.</p><p><strong>Main results: </strong>In three trials, a total of 515 participants underwent distal pancreatic resection and were randomised to closure of the pancreatic remnant either with stapler (n = 259) or scalpel resection followed by handsewn closure (n = 256). One study was a single-centre pilot RCT, and two studies were multicentre RCTs. The single-centre pilot RCT evaluated 69 participants in five intervention arms (stapler, handsewn, fibrin glue, mesh, and pancreaticojejunostomy), although we only assessed the stapler and handsewn closure groups (14 and 15 participants, respectively). The two multicentre RCTs had two interventional arms: stapler (n = 177 and 68) and handsewn closure (n = 175 and 66). Stapler may have similar effects on postoperative mortality compared to scalpel resection followed by handsewn closure, although the CI is wide (4 deaths per 1000 compared with 8 per 1000; RR 0.49, 95% CI 0.05 to 5.40; 3 RCTs; 515 participants; low","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"6 ","pages":"CD008688"},"PeriodicalIF":8.8,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12150363/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144257477","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}

{"title":"Gonadotropin-releasing hormone (GnRH) analogues for premenstrual syndrome (PMS).","authors":"Bushra Naheed, Jan Herman Kuiper, Fidelma O'Mahony, Patrick Ms O'Brien","doi":"10.1002/14651858.CD011330.pub2","DOIUrl":"10.1002/14651858.CD011330.pub2","url":null,"abstract":"<p><strong>Background: </strong>Premenstrual syndrome (PMS) is a psychological and somatic disorder affecting 20% to 30% of women of reproductive age. PMS results from ovulation: symptoms recur during the luteal phase of the menstrual cycle and remit by the end of menstruation. Premenstrual dysphoric disorder (PMDD) is a severe form of PMS experienced by three to eight per cent of menstruating women. In this review, we use the term PMS to cover all core premenstrual disorders, including PMDD. The symptoms of all types are severe enough to affect daily functioning, interfering with work, school performance or interpersonal relationships. Gonadotropin-releasing hormone (GnRH) analogues are a pharmacological treatment to suppress ovulation. They can be administered as GnRH-agonists or GnRH-antagonists, though currently, GnRH-antagonists are not generally used to treat PMS. Suppressing ovarian function induces a hypo-oestrogenic state that can cause menopausal side effects such as hot flushes and mood changes. Having menopausal side effects instead of PMS symptoms can be distressing and can confuse clinical management. Longer-term GnRH therapy carries the risk of osteoporosis. To counteract these adverse effects, oestrogen or progestogen can be added to the PMS treatment; this is known as 'add-back' therapy or simply 'add-back'. Add-back may reduce menopausal side effects, allowing GnRH therapy to be used for a longer period without reducing efficacy.</p><p><strong>Objectives: </strong>To evaluate the therapeutic effectiveness and safety (adverse effects) of GnRH analogues (agonists or antagonists), with or without add-back, in the management of PMS.</p><p><strong>Search methods: </strong>A Cochrane Information Specialist searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO and two trials registers on 29 May 2023. We also checked reference lists and contacted study authors and subject experts to identify additional studies.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) of GnRH analogues used in the management of PMS in women of reproductive age with PMS diagnosed by at least two prospective menstrual cycles and no current psychiatric disorder. Control conditions could be no treatment, placebo, another type of GnRH, another dosage of GnRH or add-back.</p><p><strong>Data collection and analysis: </strong>We used the standard methodological procedures recommended by Cochrane. Our primary outcomes were overall severity of PMS symptoms (global symptoms), quality of life and adverse events.</p><p><strong>Main results: </strong>The review found 11 RCTs that analysed results from 275 women. The evidence is of very low to high certainty. The evidence is limited by serious imprecision due to low sample sizes and a high risk of bias related to blinding and attrition. Quality of life and long-term effects on bones were not reported in the studies. Most studies","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"6 ","pages":"CD011330"},"PeriodicalIF":8.8,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12150362/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144257474","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}

{"title":"Systemic antibiotics for chronic suppurative otitis media.","authors":"Lee Yee Chong, Karen Head, Katie E Webster, Jessica Daw, Natalie A Strobel, Peter C Richmond, Tom Snelling, Mahmood F Bhutta, Anne Gm Schilder, Christopher G Brennan-Jones","doi":"10.1002/14651858.CD013052.pub3","DOIUrl":"10.1002/14651858.CD013052.pub3","url":null,"abstract":"<p><strong>Background: </strong>Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Systemic antibiotics are commonly used to treat people with CSOM. This is the first update to the review published in 2021, and is one of a suite of seven Cochrane reviews evaluating the effects of non-surgical interventions for CSOM.</p><p><strong>Objectives: </strong>To assess the effects of systemic antibiotics compared to placebo, no treatment, or another systemic antibiotic in people with chronic suppurative otitis media (CSOM).</p><p><strong>Search methods: </strong>We searched the Cochrane Ear, Nose, and Throat Register, CENTRAL, MEDLINE, Embase, four other databases, and two clinical trials registers to 15 June 2022.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials comparing systemic antibiotics (oral, injection) to placebo/no treatment or other systemic antibiotics with at least a one-week follow-up period, involving people with chronic (at least two weeks) ear discharge of unknown cause or due to CSOM. Other treatments were allowed if both treatment and control arms received it.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods. Our primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not, measured at between one week and up to two weeks, two weeks to up to four weeks, and after four weeks); health-related quality of life using a validated instrument; and ear pain (otalgia)/discomfort/local irritation. Secondary outcomes included hearing, serious complications, and ototoxicity measured in several ways. We used GRADE to assess the certainty of the evidence for each outcome.</p><p><strong>Main results: </strong>This update found three new studies (390 participants). Overall, we included 21 studies (2525 participants). We report four core comparisons below, and describe an additional four in the Results section of the review. 1. Systemic antibiotics versus no treatment/placebo It is very uncertain from a single study if there is a difference between systemic (intravenous) antibiotics and placebo in the resolution of ear discharge between one and two weeks (risk ratio (RR) 8.47, 95% confidence interval (CI) 1.88 to 38.21; 1 study, 33 participants; very low-certainty evidence). The study did not report results for resolution of ear discharge after two weeks, or health-related quality of life. The evidence is very uncertain for hearing and serious (intracranial) complications. The study did not report ear pain and suspected ototoxicity. 2. Systemic antibiotics versus no treatment/placebo (both study arms received topical antibiotics) Seven studies assessed ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"6 ","pages":"CD013052"},"PeriodicalIF":8.8,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12145956/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246779","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}

{"title":"Topical antibiotics for chronic suppurative otitis media.","authors":"Christopher G Brennan-Jones, Karen Head, Lee Yee Chong, Jessica Daw, Tamara Veselinović, Anne Gm Schilder, Mahmood F Bhutta","doi":"10.1002/14651858.CD013051.pub3","DOIUrl":"10.1002/14651858.CD013051.pub3","url":null,"abstract":"<p><strong>Background: </strong>Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media, is a chronic inflammation and often polymicrobial infection (involving more than one micro-organism) of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms are ear discharge and hearing loss. Topical antibiotics, the most common treatment for CSOM, aim to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be used alone or with other treatments for CSOM, such as antiseptics or ear cleaning (aural toileting). This is an update of a Cochrane review first published in 2020 and one of a suite of seven reviews evaluating the effects of non-surgical interventions for CSOM.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of topical antibiotics (without steroids) for people with chronic suppurative otitis media (CSOM).</p><p><strong>Search methods: </strong>We searched the Cochrane ENT Register, CENTRAL, Ovid MEDLINE, Ovid Embase, and five other databases. We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. The latest search date was 15 June 2022.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials with at least a one week of follow-up involving adults and children with chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks. The interventions were any single, or combination of, topical antibiotic(s) of any class, applied directly into the ear canal as ear drops, powders, or irrigations, or as part of an aural toileting procedure. The two main comparisons were topical antibiotic compared to placebo or no intervention, and compared to another topical antibiotic (e.g. topical antibiotic A versus topical antibiotic B).</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methodology. Our primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks and up to four weeks, and after four weeks; health-related quality of life using a validated instrument; and ear pain (otalgia) or discomfort or local irritation. Secondary outcomes were hearing, serious complications, and ototoxicity. We used GRADE to assess the certainty of the evidence for each outcome.</p><p><strong>Main results: </strong>This update found one new study (100 participants). Overall, we included 18 studies with 1783 participants (in 16 studies), plus 108 ears that could not be accounted for in participant numbers (in two studies). 1. Topical antibiotics versus placebo or no treatment (with aural toilet in both arms and no other background treatment) One study (50 participants, data unavailable for 15 participants) compared a topical antibiot","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"6 ","pages":"CD013051"},"PeriodicalIF":8.8,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Topical antiseptics for chronic suppurative otitis media.","authors":"Karen Head, Lee Yee Chong, Mahmood F Bhutta, Jessica Daw, Tamara Veselinović, Peter S Morris, Shyan Vijayasekaran, Anne Gm Schilder, Christopher G Brennan-Jones","doi":"10.1002/14651858.CD013055.pub3","DOIUrl":"10.1002/14651858.CD013055.pub3","url":null,"abstract":"<p><strong>Background: </strong>Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Topical antiseptics, a possible treatment for CSOM, inhibit the micro-organisms that may be responsible for the infection. Antiseptics can be used alone or in addition to other treatments for CSOM, such as antibiotics or ear cleaning (aural toileting). However, the effects of topical antiseptics for CSOM remain unclear. This is an update of a review last published in 2020, with one new study added. It is one of a suite of seven Cochrane reviews evaluating the effects of non-surgical interventions for CSOM.</p><p><strong>Objectives: </strong>To assess the effects of topical antiseptics for people with CSOM.</p><p><strong>Search methods: </strong>We searched the Cochrane ENT Register, CENTRAL, Ovid MEDLINE, Ovid Embase, and five other databases. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. The date of the latest search was 15 June 2022.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) with at least a one-week follow-up involving participants (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks. The interventions were any single, or combination of, topical antiseptic agent of any class, applied directly into the ear canal as ear drops, powders, or irrigations, or as part of an aural toileting procedure. The two main comparisons were topical antiseptics (a) compared to placebo or no intervention, and (b) compared to another topical antiseptic (e.g. topical antiseptic A versus topical antiseptic B). Within each comparison, we separated studies into (a) those in which both groups of participants had received aural toileting in addition to the topical antiseptics, and those where neither group had received aural toileting, and (b) those in which both groups had received some other concomitant treatment (such as antibiotics) and those with no such concomitant treatment.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methodological procedures. Our primary outcomes were resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks, and after four weeks; health-related quality of life using a validated instrument; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes were hearing, serious complications, and ototoxicity. We used GRADE to assess the certainty of the evidence for each outcome.</p><p><strong>Main results: </strong>We found one ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"6 ","pages":"CD013055"},"PeriodicalIF":8.8,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12146031/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246782","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}

{"title":"Topical versus systemic antibiotics for chronic suppurative otitis media.","authors":"Lee Yee Chong, Karen Head, Katie E Webster, Jessica Daw, Natalie A Strobel, Peter C Richmond, Tom Snelling, Mahmood F Bhutta, Anne Gm Schilder, Christopher G Brennan-Jones","doi":"10.1002/14651858.CD013053.pub3","DOIUrl":"10.1002/14651858.CD013053.pub3","url":null,"abstract":"<p><strong>Background: </strong>Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media, is a chronic inflammation and often polymicrobial infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Antibiotics are the most common treatment for CSOM, and aim to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be administered both topically and systemically, and can be used alone or in addition to other treatments for CSOM, such as ear cleaning (aural toileting). This is the first update of a review published in 2021. The update found no new studies. It is one of a suite of seven Cochrane reviews evaluating the effects of non-surgical interventions for CSOM.</p><p><strong>Objectives: </strong>To assess the benefits and harms of topical versus systemic antibiotics for people with CSOM.</p><p><strong>Search methods: </strong>We searched the Cochrane ENT Register, CENTRAL, Ovid MEDLINE, Ovid Embase, and five other databases. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform (ICTRP). The latest search date was 15 June 2022.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) with at least a one-week follow-up involving adults and children who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks. The studies compared topical antibiotics versus systemic (oral, injection) antibiotics. The two main comparisons were the same type of antibiotic in both treatment groups and different types of antibiotics in each group. Within each comparison, we separated studies into 1. those in which both groups of participants had received aural toileting in addition to the antibiotics, and those where neither group had received aural toileting, and 2. those in which both groups received some other concomitant treatment (such as topical antiseptics) and those with no such concomitant treatment.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methodological procedures. Our primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not, measured at between one week and up to two weeks, two weeks up to four weeks, and after four weeks), health-related quality of life using a validated instrument, and ear pain (otalgia) or discomfort or local irritation. Secondary outcomes were hearing, serious complications, and ototoxicity. We used GRADE to assess the certainty of the evidence for each outcome.</p><p><strong>Main results: </strong>This update did not find any new studies. We included six studies (445 participants), all with high risk of bias. Three studies included participants with confirmed CSOM, where perforation","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"6 ","pages":"CD013053"},"PeriodicalIF":8.8,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12146030/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246783","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}