Smisha Agarwal, Weng Yee Chin, Lavanya Vasudevan, Nicholas Henschke, Tigest Tamrat, Hakan Safaralilo Foss, Claire Glenton, Hanna Bergman, Marita S Fønhus, Natschja Ratanaprayul, Shivani Pandya, Garrett L Mehl, Simon Lewin
{"title":"Digital tracking, provider decision support systems, and targeted client communication via mobile devices to improve primary health care.","authors":"Smisha Agarwal, Weng Yee Chin, Lavanya Vasudevan, Nicholas Henschke, Tigest Tamrat, Hakan Safaralilo Foss, Claire Glenton, Hanna Bergman, Marita S Fønhus, Natschja Ratanaprayul, Shivani Pandya, Garrett L Mehl, Simon Lewin","doi":"10.1002/14651858.CD012925.pub2","DOIUrl":"https://doi.org/10.1002/14651858.CD012925.pub2","url":null,"abstract":"<p><strong>Background: </strong>Digital tracking on mobile devices, combined with clinical decision support systems and targeted client communication, can facilitate service delivery and potentially improve outcomes.</p><p><strong>Objectives: </strong>To assess the effects of using a mobile device to track service use when combined with clinical decision support (Tracking + CDSS), with targeted client communications (Tracking + TCC), or both (Tracking + CDSS + TCC).</p><p><strong>Search methods: </strong>Cochrane CENTRAL, MEDLINE, Embase, Ovid Population Information Online (POPLINE), K4Health and WHO Global Health Library (2000 to November 2022).</p><p><strong>Selection criteria: </strong>Randomised and non-randomised trials in community/primary care settings.</p><p><strong>Participants: </strong>primary care providers and clients Interventions: 1. Tracking + CDSS 2. Tracking + TCC 3. Tracking + CDSS + TCC Comparators: usual care (without digital tracking) DATA COLLECTION AND ANALYSIS: Two authors independently screened trials, extracted data and assessed risk of bias using the RoB 1 tool. We used a random-effects model to meta-analyse data producing risk differences (RD), risk ratios (RR), or odds ratios (OR) for dichotomous outcomes and mean differences (MD) for continuous outcomes. Evidence certainty was assessed using GRADE.</p><p><strong>Main results: </strong>We identified 18 eligible studies (11 randomised, seven non-randomised) conducted in Bangladesh, China, Ethiopia, India, Kenya, Palestine, Uganda, and the USA. All non-randomised studies had a high risk of bias. These results are from randomised studies. 'Probably/may/uncertain' indicates 'moderate/low/very low' certainty evidence. Tracking + CDSS Relating to antenatal/ postnatal care: Providers' adherence to recommendations May slightly increase home visits in the week following delivery (2 studies, 4531 participants; RD 0.10 [0.07, 0.14]) May slightly increase counselling for initiating complementary feeding (2 studies, 4397 participants; RD 0.12 [0.08, 0.15]) May slightly increase the mean number of home visits in the month following delivery (1 study, 3023 participants; MD 0.75 [0.47, 1.03]) Uncertain effect on home visits within 24 hours of delivery Clients' health behaviours May slightly increase skin-to-skin care (1 study, 1544 participants; RD 0.05 [0.00, 0.10]) May slightly increase early breastfeeding (2 studies, 4540 participants; RD 0.08 [0.05, 0.12]) Uncertain effects on applying nothing to the umbilical cord, taking ≥ 90 iron-folate tablets during pregnancy, exclusively breastfeeding for six months, delaying the newborn's bath at least two days and Kangaroo Mother Care. Clients' health status May reduce low birthweight babies (1 study, 3023 participants; RR 0.53 [0.38, 0.73]) May increase infants with pneumonia or fever seeking care (1 study, 3470 participants; RR 1.13 [1.03, 1.24]) Uncertain effects on stillbirths, neonatal and infant deaths, or testing positive for HIV d","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"4 ","pages":"CD012925"},"PeriodicalIF":8.8,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794799","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}
Nienke S Weiss, Elena B Kostova, Ben Willem J Mol, Madelon van Wely
{"title":"Gonadotropins for ovulation induction in women with polycystic ovary syndrome.","authors":"Nienke S Weiss, Elena B Kostova, Ben Willem J Mol, Madelon van Wely","doi":"10.1002/14651858.CD010290.pub4","DOIUrl":"https://doi.org/10.1002/14651858.CD010290.pub4","url":null,"abstract":"<p><strong>Rationale: </strong>Ovulation induction with follicle-stimulating hormone (FSH) is a second-line treatment in women with polycystic ovary syndrome (PCOS) who do not ovulate or conceive on clomiphene citrate or letrozole, though induction protocols and types of gonadotropins used vary greatly.</p><p><strong>Objectives: </strong>To compare the effectiveness and safety of gonadotropins as a second-line treatment for ovulation induction in women with PCOS who do not ovulate or conceive after clomiphene citrate or letrozole.</p><p><strong>Search methods: </strong>In March 2024, we searched the Cochrane Gynaecology and Fertility Group Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase and PsycINFO. We checked references of all relevant studies. We had no language or date restrictions.</p><p><strong>Eligibility criteria: </strong>All randomised controlled trials (RCTs) reporting data on clinical outcomes in women with PCOS who did not ovulate or conceive on clomiphene citrate or letrozole, and were undergoing ovulation induction with urinary-derived gonadotropins, including urofollitropin in purified FSH (uFSH) or highly purified FSH (HP-FSH) form, human menopausal gonadotropin (HMG) and highly purified human menopausal gonadotropin (HP-HMG), or recombinant FSH (rFSH) were eligible. We included trials reporting on ovulation induction followed by intercourse or intrauterine insemination. We excluded studies that described co-treatment with clomiphene citrate, metformin, luteinising hormone, or letrozole.</p><p><strong>Outcomes: </strong>We implemented the core outcome set for infertility. Our critical outcomes were live birth rate and multiple pregnancy rate per woman. Important outcomes were clinical pregnancy, pregnancy loss, incidence of ovarian hyperstimulation syndrome (OHSS) per woman, total gonadotropin dose, total duration of stimulation per woman, gestational age at birth, birthweight, neonatal mortality, and major congenital anomaly.</p><p><strong>Risk of bias: </strong>We used the Cochrane RoB 1 tool to assess bias in the included studies.</p><p><strong>Synthesis methods: </strong>Where meta-analysis was possible, we combined data using a fixed-effect model to calculate the risk ratio (RR) or mean difference. We summarised the overall certainty of evidence for the main outcomes using GRADE criteria.</p><p><strong>Included studies: </strong>We included 15 studies with 2348 women. Ten trials compared rFSH with urinary-derived gonadotropins (one compared rFSH with human menopausal gonadotropin (HMG), and nine compared rFSH with urinary FSH). Three trials compared HMG with purified FSH (uFSH). One trial compared HP-FSH with purified FSH (uFSH) and one trial compared gonadotropins with continued clomiphene citrate.</p><p><strong>Synthesis of results: </strong>Recombinant FSH (rFSH) versus urinary-derived gonadotropins There may be little or no difference in the birth rate between rFSH and urinary-derived gonadotropins (R","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"4 ","pages":"CD010290"},"PeriodicalIF":8.8,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794800","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}
Sara Pessano, Maria Boldor, Francesca Faravelli, Michelle Fiander, Karsten Juhl Jørgensen, Roger F Soll, Matteo Bruschettini
{"title":"Next-generation sequencing (NGS) techniques for pre-symptomatic identification of genetic diseases in newborns.","authors":"Sara Pessano, Maria Boldor, Francesca Faravelli, Michelle Fiander, Karsten Juhl Jørgensen, Roger F Soll, Matteo Bruschettini","doi":"10.1002/14651858.CD016118","DOIUrl":"https://doi.org/10.1002/14651858.CD016118","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the benefits and harms of using NGS techniques compared to conventional newborn screening alone for pre-symptomatic identification of genetic diseases in newborns.</p><p><strong>Secondary objectives: </strong>to explore equity and ethical issues in the application of the new techniques, to inform healthcare decisions by families, carers, and policymakers.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"4 ","pages":"CD016118"},"PeriodicalIF":8.8,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794803","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}
Lucian Puscasiu, Beverley Vollenhoven, Helen E Nagels, Ioana-Marta Melinte, Marian G Showell, Anne Lethaby
{"title":"Preoperative medical therapy before surgery for uterine fibroids.","authors":"Lucian Puscasiu, Beverley Vollenhoven, Helen E Nagels, Ioana-Marta Melinte, Marian G Showell, Anne Lethaby","doi":"10.1002/14651858.CD000547.pub3","DOIUrl":"10.1002/14651858.CD000547.pub3","url":null,"abstract":"<p><strong>Background: </strong>Uterine fibroids occur in up to 40% of women over 35 years of age. Up to 50% of uterine fibroids cause symptoms that warrant treatment: anaemia caused by heavy menstrual bleeding, pelvic pain, dysmenorrhoea, infertility and poor quality of life. Surgery is the first choice of treatment, but medical therapies have been used prior to surgery to improve outcomes. Gonadotropin-hormone-releasing analogues (GnRHa) induce a low-oestrogen state that shrinks fibroids, but they have unacceptable side effects if used long-term. Other potential hormonal treatments include progestins and selective progesterone-receptor modulators (SPRMs). This updates a Cochrane review published in 2017.</p><p><strong>Objectives: </strong>To assess the benefits and risks of medical treatments prior to surgery for uterine fibroids.</p><p><strong>Search methods: </strong>We searched the Cochrane Gynaecology and Fertility Group Specialized Register, CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL on 8 August 2024. We also searched trials registers (ClinicalTrials.gov; WHO ICTRP), theses and dissertations, and grey literature, as well as handsearching reference lists of retrieved articles and contacting pharmaceutical companies.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials of premenopausal women receiving medical therapy before myomectomy, hysterectomy or hysteroscopic resection for uterine fibroids versus placebo, no pretreatment or another medical therapy.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods. We assessed the certainty of the evidence using GRADE.</p><p><strong>Main results: </strong>We included 41 RCTs, which involved 3982 women. Thirty-six studies evaluated GnRHa: the comparators were no pretreatment (19 studies), placebo (9 studies), or other medical pretreatments (progestin, SPRMs, selective oestrogen receptor modulators (SERMs), dopamine agonists, oestrogen receptor antagonists) (8 studies). Five studies evaluated SPRMs versus placebo. Most results provided low-certainty evidence due to poor reporting of randomisation procedures, lack of blinding, imprecision and inconsistency. Some outcomes were not measured or did not have usable data. The use of ulipristal acetate (an SPRM) is suspended at this time (March 2025) because of an association with cases of liver failure. GnRHa versus placebo or no pretreatment before surgery for uterine fibroids GnRHa pretreatment may reduce uterine volume (mean difference (MD) -175.34 mL, 95% confidence interval (CI) -219.04 to -131.65; 13 studies, 858 participants; I² = 67%; low-certainty evidence) and fibroid volume (MD range 5.7 mL to 155.4 mL; 5 studies to heterogeneous to pool, 427 participants; low-certainty evidence), and probably increases preoperative haemoglobin (MD 0.88 g/dL, 95% CI 0.68 to 1.08; 10 studies, 834 participants; I² = 0%; moderate-certainty evidence). However, there is probably a greater likelihood o","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"4 ","pages":"CD000547"},"PeriodicalIF":8.8,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969932/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779338","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}
Yuji Oba, Mona Pathak, Tinashe Maduke, Eddie W Fakhouri, Sofia Dias
{"title":"Dual combination therapy versus long-acting bronchodilators alone for chronic obstructive pulmonary disease (COPD): a systematic review and network meta-analysis.","authors":"Yuji Oba, Mona Pathak, Tinashe Maduke, Eddie W Fakhouri, Sofia Dias","doi":"10.1002/14651858.CD015997","DOIUrl":"10.1002/14651858.CD015997","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the comparative efficacy and safety of fixed-dose dual inhalers (i.e. LABA/LAMA versus ICS/LABA) and combination therapies versus LABA or LAMA monotherapy in individuals with moderate to very severe COPD, using network meta-analysis, and to rank these treatments based on their efficacy and safety.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"4 ","pages":"CD015997"},"PeriodicalIF":8.8,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11967328/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771585","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}
Anna Badura, Michelle Fiander, Anna Gabriel, Matteo Pirinu, Laura Beccani, Roger F Soll, Jane Cracknell, Dirk Faas, Sven Wellmann, Matteo Bruschettini
{"title":"In-hospital motor interventions to reduce neurodevelopmental impairment in preterm infants: a scoping review.","authors":"Anna Badura, Michelle Fiander, Anna Gabriel, Matteo Pirinu, Laura Beccani, Roger F Soll, Jane Cracknell, Dirk Faas, Sven Wellmann, Matteo Bruschettini","doi":"10.1002/14651858.CD016181","DOIUrl":"10.1002/14651858.CD016181","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (prototype). The objectives are as follows: The aim of this scoping review is to map the quantitative literature about in-hospital motor interventions used to reduce neurodevelopmental impairment in preterm infants. We will collate information about the features, delivery mechanisms, objectives, providers, underlying theoretical frameworks, hypothesized or reported outcomes of these interventions, and equity characteristics of the population. The goal will be to document the breadth and characteristics of available evidence and to identify gaps or areas of knowledge in the field of motor interventions. Subcategories: Identify motor interventions initiated during neonatal intensive care unit stays for preterm infants Identify techniques, elements, and modalities in each intervention Determine the theories underlying these interventions Describe the extent to which the interventions are parent-centered Synthesize and categorize the different motor interventions.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"4 ","pages":"CD016181"},"PeriodicalIF":8.8,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11967329/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771589","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}
Lucia B Varela, Camila Micaela Escobar Liquitay, Samanta Díaz Menai, Luis Garegnani
{"title":"Medical cannabis for the treatment of insomnia.","authors":"Lucia B Varela, Camila Micaela Escobar Liquitay, Samanta Díaz Menai, Luis Garegnani","doi":"10.1002/14651858.CD016216","DOIUrl":"10.1002/14651858.CD016216","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 medical cannabis on adults with insomnia.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"4 ","pages":"CD016216"},"PeriodicalIF":8.8,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11967163/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771610","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}
Huanyu Mou, Wai Tong Chien, Ho Yu Cheng, Suzanne Hoi Shan Lo, Mimi Wai Man Chan, Shanshan Kong, Kai Chow Choi
{"title":"Motivational interviewing for improving functional and psychosocial outcomes among stroke survivors.","authors":"Huanyu Mou, Wai Tong Chien, Ho Yu Cheng, Suzanne Hoi Shan Lo, Mimi Wai Man Chan, Shanshan Kong, Kai Chow Choi","doi":"10.1002/14651858.CD016110","DOIUrl":"10.1002/14651858.CD016110","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the benefits and harms of motivational interviewing for functional and psychosocial outcomes in stroke survivors, compared to no intervention, waiting list, or attention controls.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"4 ","pages":"CD016110"},"PeriodicalIF":8.8,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11967331/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771616","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}
Sarah Alsamman, David M Haas, Insiyyah Patanwala, David A Klein, Kelly Kasper, Charlotte M Pickett
{"title":"Transversus abdominis plane (TAP) blocks for prevention of postoperative pain in women undergoing laparoscopic and robotic gynaecological surgery.","authors":"Sarah Alsamman, David M Haas, Insiyyah Patanwala, David A Klein, Kelly Kasper, Charlotte M Pickett","doi":"10.1002/14651858.CD015145.pub2","DOIUrl":"10.1002/14651858.CD015145.pub2","url":null,"abstract":"<p><strong>Rationale: </strong>Pain control following laparoscopic gynaecologic surgery is key to successful recovery. The efficacy of the transversus abdominis plane (TAP) block compared to no block or a local anaesthetic injection has not been well established in this population.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of single-shot transversus abdominis plane blocks for the prevention of postoperative pain in women undergoing laparoscopic and robotic gynaecological surgery compared to no block, sham block, or injection of local anaesthetic.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, two trials registers, and handsearched abstracts to 6 December 2024.</p><p><strong>Eligibility criteria: </strong>We included prospective randomised controlled trials (RCTs) of adult women undergoing minimally invasive gynaecologic surgery that compared single-shot TAP block to no block, sham block, or injection of local anaesthetic. We excluded studies that were non-randomised or of non-gynaecologic surgery.</p><p><strong>Outcomes: </strong>Critical and important outcomes: participant-reported pain intensity 24 hours following surgery (combined, at rest, and with movement), adverse events (serious adverse events, nausea and vomiting, postoperative sedation), opioid consumption 24 and 48 hours after surgery. Other outcomes: pain intensity 2, 6, 12, and 48 hours after surgery, opioid consumption intraoperatively, time from surgery to first participant requirement for postoperative opioid, time from surgery until discharge.</p><p><strong>Risk of bias: </strong>We assessed the risk of bias with RoB 1.</p><p><strong>Synthesis methods: </strong>We conducted meta-analyses using random-effects models. We calculated mean differences (MD) for continuous outcomes and risk ratios (RR) for dichotomous outcomes. We reported serious adverse events as described by the study authors. We summarised the certainty of evidence using GRADE methods.</p><p><strong>Included studies: </strong>We included 21 RCTs with a total of 1645 participants. Studies were conducted in 10 countries, and published between 2011 and 2023. Six studies compared TAP block to no block, eight compared TAP block to an injection of local anaesthetic, and seven studies compared TAP block to sham block. Studies reported pain outcomes in various ways, so we made assumptions to allow us to combine data.</p><p><strong>Synthesis of results: </strong>1. TAP block compared to no block TAP blocks may result in little or no difference in pain 24 hours after surgery for women undergoing laparoscopic or robotic gynaecologic procedures (MD -4.66, 95% confidence interval (CI) -11.06 to 1.74; 4 RCTs, 242 women; I<sup>2</sup> = 88%; very low-certainty evidence). TAP blocks may result in little or no difference in pain at rest (MD -0.16, 95% CI -1.60 to 1.28; 2 RCTs, 146 women; I<sup>2</sup> = 0%, low-certainty evidence), or pain with movement (MD -1.59, 95% CI -4.4","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"4 ","pages":"CD015145"},"PeriodicalIF":8.8,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11967164/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771627","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}
Samuel L Whittle, Renea V Johnston, Steve McDonald, Daniel Worthley, T Mark Campbell, Sheila Cyril, Tanay Bapna, Jason Zhang, Rachelle Buchbinder
{"title":"Stem cell injections for osteoarthritis of the knee.","authors":"Samuel L Whittle, Renea V Johnston, Steve McDonald, Daniel Worthley, T Mark Campbell, Sheila Cyril, Tanay Bapna, Jason Zhang, Rachelle Buchbinder","doi":"10.1002/14651858.CD013342.pub2","DOIUrl":"10.1002/14651858.CD013342.pub2","url":null,"abstract":"<p><strong>Background: </strong>Stem cells are specialised precursor cells that can replace aged or damaged cells and thereby maintain healthy tissue function. Stem cell therapy is increasingly used as a treatment for knee osteoarthritis, despite the lack of clarity around the mechanism by which stem cell therapy may slow down disease progression in osteoarthritis, and uncertainty regarding its benefits and harms.</p><p><strong>Objectives: </strong>To assess the benefits and harms of stem cell injections for people with osteoarthritis of the knee. A secondary objective is to maintain the currency of the evidence, using a living systematic review approach.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase on 15 September 2023, unrestricted by date or language of publication. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) for relevant trial protocols and ongoing trials.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs), or trials using quasi-randomised methods of participant allocation, comparing stem cell injection with placebo injection, no treatment or usual care, glucocorticoid injection, other injections, exercise, drug therapy, surgical interventions, and supplements and complementary therapies in people with knee osteoarthritis.</p><p><strong>Data collection and analysis: </strong>Two review authors selected studies for inclusion, extracted trial characteristics and outcome data, assessed risk of bias and assessed the certainty of evidence using the GRADE approach. The primary comparison was stem cell injection compared with placebo injection. The primary time point for pain, function and quality of life was three to six months, and the end of the trial period for participant-reported success, joint structure changes and adverse event outcomes. Major outcomes were pain, function, quality of life, global assessment of success, radiographic joint progression, withdrawals due to adverse events and serious adverse events.</p><p><strong>Main results: </strong>We found 25 randomised trials (1341 participants) comparing stem cell injections with placebo injection (eight trials), no treatment or usual care (analgesia, weight loss and exercise) (two trials), glucocorticoid injection (one trial), hyaluronic acid injection (seven trials), platelet-rich plasma injections (two trials), oral acetaminophen (paracetamol) (one trial), non-steroidal anti-inflammatory drugs plus physical therapy plus hyaluronic acid injection (one trial) and stem cell injection plus intra-articular co-intervention versus co-intervention alone (three trials) in people with osteoarthritis of the knee. Trials were predominantly small, with sample sizes ranging from 6 to 252 participants, with only two trials having more than 100 participants. The average age of participants across trials ranged from 51 ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"4 ","pages":"CD013342"},"PeriodicalIF":8.8,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11961299/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143762454","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}