The International Journal Of Risk & Safety In Medicine[JOURNAL]
Sun
200 papers
Tuberculosis preventive therapy for people living with HIV: A systematic review and network meta-analysis.
Yanes-Lane M, Ortiz-Brizuela E, Campbell JR … +4 more , Benedetti A, Churchyard G, Oxlade O, Menzies D
PLoS Med · 2021 Sep · PMID 34520459 · Full text
BACKGROUND: Tuberculosis (TB) preventive therapy (TPT) is an essential component of care for people living with HIV (PLHIV). We compared efficacy, safety, completion, and drug-resistant TB risk for currently recommended...
BACKGROUND: Tuberculosis (TB) preventive therapy (TPT) is an essential component of care for people living with HIV (PLHIV). We compared efficacy, safety, completion, and drug-resistant TB risk for currently recommended TPT regimens through a systematic review and network meta-analysis (NMA) of randomized trials. METHODS AND FINDINGS: We searched MEDLINE, Embase, and the Cochrane Library from inception through June 9, 2020 for randomized controlled trials (RCTs) comparing 2 or more TPT regimens (or placebo/no treatment) in PLHIV. Two independent reviewers evaluated eligibility, extracted data, and assessed the risk of bias. We grouped TPT strategies as follows: placebo/no treatment, 6 to 12 months of isoniazid, 24 to 72 months of isoniazid, and rifamycin-containing regimens. A frequentist NMA (using graph theory) was carried out for the outcomes of development of TB disease, all-cause mortality, and grade 3 or worse hepatotoxicity. For other outcomes, graphical descriptions or traditional pairwise meta-analyses were carried out as appropriate. The potential role of confounding variables for TB disease and all-cause mortality was assessed through stratified analyses. A total of 6,466 unique studies were screened, and 157 full texts were assessed for eligibility. Of these, 20 studies (reporting 16 randomized trials) were included. The median sample size was 616 (interquartile range [IQR], 317 to 1,892). Eight were conducted in Africa, 3 in Europe, 3 in the Americas, and 2 included sites in multiple continents. According to the NMA, 6 to 12 months of isoniazid were no more efficacious in preventing microbiologically confirmed TB than rifamycin-containing regimens (incidence rate ratio [IRR] 1.0, 95% CI 0.8 to 1.4, p = 0.8); however, 6 to 12 months of isoniazid were associated with a higher incidence of all-cause mortality (IRR 1.6, 95% CI 1.2 to 2.0, p = 0.02) and a higher risk of grade 3 or higher hepatotoxicity (risk difference [RD] 8.9, 95% CI 2.8 to 14.9, p = 0.004). Finally, shorter regimens were associated with higher completion rates relative to longer regimens, and we did not find statistically significant differences in the risk of drug-resistant TB between regimens. Study limitations include potential confounding due to differences in posttreatment follow-up time and TB incidence in the study setting on the estimates of incidence of TB or all-cause mortality, as well as an underrepresentation of pregnant women and children. CONCLUSIONS: Rifamycin-containing regimens appear safer and at least as effective as isoniazid regimens in preventing TB and death and should be considered part of routine care in PLHIV. Knowledge gaps remain as to which specific rifamycin-containing regimen provides the optimal balance of efficacy, completion, and safety.
Evaluation of a package of risk-based pharmaceutical and lifestyle interventions in patients with hypertension and/or diabetes in rural China: A pragmatic cluster randomised controlled trial.
Wei X, Zhang Z, Chong MKC … +7 more , Hicks JP, Gong W, Zou G, Zhong J, Walley JD, Upshur REG, Yu M
PLoS Med · 2021 Jul · PMID 34197452 · Full text
BACKGROUND: Primary prevention of cardiovascular disease (CVD) requires adequate control of hypertension and diabetes. We designed and implemented pharmaceutical and healthy lifestyle interventions for patients with diab...
BACKGROUND: Primary prevention of cardiovascular disease (CVD) requires adequate control of hypertension and diabetes. We designed and implemented pharmaceutical and healthy lifestyle interventions for patients with diabetes and/or hypertension in rural primary care, and assessed their effectiveness at reducing severe CVD events. METHODS AND FINDINGS: We used a pragmatic, parallel group, 2-arm, controlled, superiority, cluster trial design. We randomised 67 township hospitals in Zhejiang Province, China, to intervention (34) or control (33). A total of 31,326 participants were recruited, with 15,380 in the intervention arm and 15,946 in the control arm. Participants had no known CVD and were either patients with hypertension and a 10-year CVD risk of 20% or higher, or patients with type 2 diabetes regardless of their CVD risk. The intervention included prescription of a standardised package of medicines, individual advice on lifestyle change, and adherence support. Control was usual hypertension and diabetes care. In both arms, as usual in China, most outpatient drug costs were out of pocket. The primary outcome was severe CVD events, including coronary heart disease and stroke, during 36 months of follow-up, as recorded by the CVD surveillance system. The study was implemented between December 2013 and May 2017. A total of 13,385 (87%) and 14,745 (92%) participated in the intervention and control arms, respectively. Their mean age was 64 years, 51% were women, and 90% were farmers. Of all participants, 64% were diagnosed with hypertension with or without diabetes, and 36% were diagnosed with diabetes only. All township hospitals and participants completed the 36-month follow-up. At 36 months, there were 762 and 874 severe CVD events in the intervention and control arms, respectively, yielding a non-significant effect on CVD incidence rate (1.92 and 2.01 per 100 person-years, respectively; crude incidence rate ratio = 0.90 [95% CI: 0.74, 1.08; P = 0.259]). We observed significant, but small, differences in the change from baseline to follow-up for systolic blood pressure (-1.44 mm Hg [95% CI: -2.26, -0.62; P < 0.001]) and diastolic blood pressure (-1.29 mm Hg [95% CI: -1.77, -0.80; P < 0.001]) in the intervention arm compared to the control arm. Self-reported adherence to recommended medicines was significantly higher in the intervention arm compared with the control arm at 36 months. No safety concerns were identified. Main study limitations include all participants being informed about their high CVD risk at baseline, non-blinding of participants, and the relatively short follow-up period available for judging potential changes in rates of CVD events. CONCLUSIONS: The comprehensive package of pharmaceutical and healthy lifestyle interventions did not reduce severe CVD events over 36 months. Improving health system factors such as universal coverage for the cost of essential medicines is required for successful risk-based CVD prevention programmes. TRIAL REGISTRATION: ISRCTN registry ISRCTN58988083.
Effects and safety of acne vulgaris with external application of herbal medicines: A protocol for systematic review and meta analysis.
Zhou J, Li X, Chen H … +4 more , Qi Z, Shao S, Tang Y, Jiang C
Medicine (Baltimore) · 2021 Jul · PMID 34190157 · Full text
BACKGROUND: Acne vulgaris (AV) is a common dermatologic disease. The morbidity is increasing annually. External application of herbal medicines (EAHM) has been pervasively used in the therapy of AV. EAHM , as the traditi...
BACKGROUND: Acne vulgaris (AV) is a common dermatologic disease. The morbidity is increasing annually. External application of herbal medicines (EAHM) has been pervasively used in the therapy of AV. EAHM , as the traditional Chinese therapy, is widely applied in clinical trials for AV. The aim of this review is to systematically evaluate the efficacy and safety of EAHM in the therapy for AV. METHODS: We will conduct an electronic search of 13 databases from their inception to May, 2020, including PubMed, EMBASE, MEDLINE, Web of Science, Cochrane Library, SpringerLink, WHO International Clinical Trials Registry Platform, Wanfang China database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific Journal Database, as well as China's Conference Papers Database and China Dissertation database. Other valid search strategies will also be retrieved to complete this review. All randomized controlled trials in which EAHM was used for the treatment of AV will be adopted. Two researchers will select eligible studies respectively according to a predefined protocol. Methodological quality will be assessed with Cochrane risk of bias by means of RevMan V.5.3.5 software. RESULTS: This systematic view will present a high-quality synthesis based on current evidence of EAHM intervention for AV patients. CONCLUSION: The summary of our systematic view will provide evidence to judge whether EAHM is an effective and safe intervention for AV patients.
The effect of mind-body exercise on blood pressure in middle-aged and elderly patients with hypertension: A protocol for a systematic review and meta-analysis.
Ge B, Chen H, Liao X
Medicine (Baltimore) · 2021 Jun · PMID 34160441 · Full text
BACKGROUND: Depending on the person, cervical spondylosis may have no clinical symptoms, but cervical spondylosis will definitely cause changes in people's blood pressure, which will further affect physical and mental he...
BACKGROUND: Depending on the person, cervical spondylosis may have no clinical symptoms, but cervical spondylosis will definitely cause changes in people's blood pressure, which will further affect physical and mental health. OBJECTIVES: This study aims to explore the effect and safety of mind-body exercise intervention on the blood pressure in middle-aged and elderly patients with hypertension through meta-analysis. METHODS: This meta-analysis searched studies from 4 research databases: the China National Knowledge Infrastructure (from 1979), Web of Science (from 1950), PubMed (from 1965), and Cochrane (from 1991), Date of retrieval: January 22, 2021, Two authors will independently search literature records, scan titles, abstracts, and full texts, collect data, and assess materials for risk of bias. The data will be analyzed by Stata 14.0 software. RESULTS: The present study is a systematic review and meta-analysis program with no results. Data analysis will be completed after the program has been completed. DISCUSSION: This meta-analysis may provide clinical practice with more reliable evidence-based medical evidence that mind-body exercise can benefit the blood pressure of middle-aged and elderly hypertensive patients. INPLASY REGISTRATION NUMBER: INPLASY202130072.
Efficacy of Jihwangeumja (Dihuang Yinzi) on cognitive function and activities of daily living in patients with Alzheimer disease: A protocol for a systematic review and meta-analysis.
Lee JY, Kim JY, Lee JY … +2 more , Jung JH, Jung IC
Medicine (Baltimore) · 2021 May · PMID 34106590 · Full text
BACKGROUND: This systematic review protocol describes the methods proposed to evaluate the efficacy and safety of Jihwangeumja in patients with Alzheimer disease. METHODS: The following databases, PubMed, EMBASE, CENTRAL...
BACKGROUND: This systematic review protocol describes the methods proposed to evaluate the efficacy and safety of Jihwangeumja in patients with Alzheimer disease. METHODS: The following databases, PubMed, EMBASE, CENTRAL, Cumulative Index to Nursing and Allied Health Literature, China National Knowledge Infrastructure, National Digital Science Library, Korean Information Service System, and Korean Medical Database will be searched for relevant publications without language or publication status restrictions. Search terms will be based on "Alzheimer" for participants and "Jihwangeumja" or "Dihuang Yinzi" for interventions. Two researchers will independently extract the study data from the included studies and only randomized controlled trials will be included. The risk of bias will also be assessed independently by 2 researchers using the Cochrane risk of bias tool. We will use RevMan software random-effects and fixed-effect models for the assessment of heterogeneity and data synthesis. Any changes in the plan for documenting significant protocol amendments will require the researchers to have a revision agreement and register the international prospective register of systematic review modification. RESULTS: The treatment effect and safety will be measured by meta-analysis and the quality of the included studies will be reviewed. CONCLUSION: This systematic review will provide evidence regarding the efficacy and safety of Jihwangeumja. ETHICS AND DISSEMINATION: Ethical approval is not required because individual patient data will not be included in this paper. The study findings will be disseminated through conference presentations. OSF REGISTRATION: DOI: 10.17605/OSF.IO/HXA58.
Exercise training in patients with corrected tetralogy of Fallot: A protocol for systematic review and meta-analysis.
Gong YQ, Liu XY, Zhi P … +5 more , Wei LN, Guo FF, Qian JZ, Wang YX, Dong HL
Medicine (Baltimore) · 2021 May · PMID 34032753 · Full text
BACKGROUND: The arrival of transcatheter mitral valve therapies has provided feasible and safe alternatives to medical and surgical treatments for mitral regurgitation. The aim of this study is to estimate the relative e...
BACKGROUND: The arrival of transcatheter mitral valve therapies has provided feasible and safe alternatives to medical and surgical treatments for mitral regurgitation. The aim of this study is to estimate the relative efficacy and safety of exercise training in patients with corrected tetralogy of Fallot through meta-analysis. METHODS: : A systematic search will be performed using PubMed, EMBASE, the Cochrane Library, Web of Science, CBM, CNKI, WanFang Data, and VIP to include random controlled trials or nonrandom controlled trials comparing the efficacy and safety of exercise training in corrected tetralogy of Fallot patients. The risk of bias for the included nonrandom controlled studies will be evaluated according to Risk of Bias in Nonrandomized Studies of Interventions. We will use the Cochrane Collaboration's tool (version 2 of the Cochrane risk of bias tool for randomized trials) to assess risk of bias of included random controlled trials. Revman 5.4 and STATA 15.0 will be used to complete the meta-analysis and generate forest plots. Grading of recommendations assessment, development, and evaluation will be used to assess the quality of evidence. RESULTS: : The results of this systematic review and meta-analysis will be submitted to a peer-reviewed journal for publication. CONCLUSION: : This study will provide broad evidence of efficacy and safety of exercise training in patients with corrected tetralogy of Fallot and provide suggestions for clinical practice and future research. PROTOCOL REGISTRATION NUMBER: INPLASY202150006.
Comparative efficacy and safety of intravenous ferric carboxymaltose and iron sucrose for iron deficiency anemia in obstetric and gynecologic patients: A systematic review and meta-analysis.
Shin HW, Go DY, Lee SW … +4 more , Choi YJ, Ko EJ, You HS, Jang YK
Medicine (Baltimore) · 2021 May · PMID 34011020 · Full text
INTRODUCTION: Iron deficiency anemia (IDA) is common among obstetric and gynecologic patients. This systematic review aimed to assess the comparative efficacy and safety of commonly used intravenous (IV) iron formulation...
INTRODUCTION: Iron deficiency anemia (IDA) is common among obstetric and gynecologic patients. This systematic review aimed to assess the comparative efficacy and safety of commonly used intravenous (IV) iron formulations, ferric carboxymaltose (FCM), and iron sucrose (IS) in the treatment of IDA in obstetric and gynecologic patients. METHODS: We systematically searched PubMed, EMBASE, Cochrane CENTRAL, and Google Scholar for eligible randomized controlled trials (RCTs) comparing IV iron replacement using FCM and IS up to October 2019. The primary outcome was to compare the efficacy of FCM and IS, assessed by measuring serum hemoglobin (Hb) and ferritin levels before and after iron replacement. The secondary outcome was to compare the safety of FCM and IS, assessed by the incidence of adverse events during iron replacement. The meta-analysis was performed using RevMan 5.3. RESULTS: We identified 9 RCTs with 910 patients (FCM group, n = 456; IS group, n = 454). Before iron replacement, FCM and IS group patients had similar baseline Hb (mean difference [MD], 0.04 g/dL; 95% confidence interval [CI], -0.07 to 015; I2 = 0%; P = 0.48) and ferritin levels (MD, -0.42 ng/mL; 95% CI, -1.61 to 0.78; I2 = 45%; P = 0.49). Following iron replacement, patients who received FCM had higher Hb (MD, 0.67; 95% CI, 0.25-1.08; I2 = 92%; P = 0.002) and ferritin levels (MD, 24.41; 95% CI, 12.06-36.76; I2 = 75%; P = 0.0001) than patients who received IS. FCM group showed a lower incidence of adverse events following iron replacement than IS group (risk ratio, 0.53; 95% CI, 0.35-0.80; I2 = 0%; P = 0.003). Serious adverse events were not reported in any group. CONCLUSION: FCM group showed better efficacy in increasing Hb and ferritin levels and a favorable safety profile with fewer adverse events compared with IS group for IDA treatment among obstetric and gynecologic patients. However, this meta-analysis was limited by the small number of RCTs and high heterogeneity. TRIAL REGISTRATION: The review was prospectively registered with the International Prospective Registry of Systematic Reviews (https://www.crd.york.ac.uk/prospero/, registration number CRD42019148905).
Effect of community-led delivery of HIV self-testing on HIV testing and antiretroviral therapy initiation in Malawi: A cluster-randomised trial.
Indravudh PP, Fielding K, Kumwenda MK … +10 more , Nzawa R, Chilongosi R, Desmond N, Nyirenda R, Neuman M, Johnson CC, Baggaley R, Hatzold K, Terris-Prestholt F, Corbett EL
PLoS Med · 2021 May · PMID 33974621 · Full text
BACKGROUND: Undiagnosed HIV infection remains substantial in key population subgroups including adolescents, older adults, and men, driving ongoing transmission in sub-Saharan Africa. We evaluated the impact, safety, and...
BACKGROUND: Undiagnosed HIV infection remains substantial in key population subgroups including adolescents, older adults, and men, driving ongoing transmission in sub-Saharan Africa. We evaluated the impact, safety, and costs of community-led delivery of HIV self-testing (HIVST), aiming to increase HIV testing in underserved subgroups and stimulate demand for antiretroviral therapy (ART). METHODS AND FINDINGS: This cluster-randomised trial, conducted between October 2018 and July 2019, used restricted randomisation (1:1) to allocate 30 group village head clusters in Mangochi district, Malawi to the community-led HIVST intervention in addition to the standard of care (SOC) or the SOC alone. The intervention involved mobilising community health groups to lead the design and implementation of 7-day HIVST campaigns, with cluster residents (≥15 years) eligible for HIVST. The primary outcome compared lifetime HIV testing among adolescents (15 to 19 years) between arms. Secondary outcomes compared: recent HIV testing (in the last 3 months) among older adults (≥40 years) and men; cumulative 6-month incidence of ART initiation per 100,000 population; knowledge of the preventive benefits of HIV treatment; and HIV testing stigma. Outcomes were measured through a post-intervention survey and at neighboring health facilities. Analysis used intention-to-treat for cluster-level outcomes. Community health groups delivered 24,316 oral fluid-based HIVST kits. The survey included 90.2% (3,960/4,388) of listed participants in the 15 community-led HIVST clusters and 89.2% (3,920/4,394) of listed participants in the 15 SOC clusters. Overall, the proportion of men was 39.0% (3,072/7,880). Most participants obtained primary-level education or below, were married, and reported a sexual partner. Lifetime HIV testing among adolescents was higher in the community-led HIVST arm (84.6%, 770/910) than the SOC arm (67.1%, 582/867; adjusted risk difference [RD] 15.2%, 95% CI 7.5% to 22.9%; p < 0.001), especially among 15 to 17 year olds and boys. Recent testing among older adults was also higher in the community-led HIVST arm (74.5%, 869/1,166) than the SOC arm (31.5%, 350/1,111; adjusted RD 42.1%, 95% CI 34.9% to 49.4%; p < 0.001). Similarly, the proportions of recently tested men were 74.6% (1,177/1,577) and 33.9% (507/1,495) in the community-led HIVST and SOC arms, respectively (adjusted RD 40.2%, 95% CI 32.9% to 47.4%; p < 0.001). Knowledge of HIV treatment benefits and HIV testing stigma showed no differences between arms. Cumulative incidence of ART initiation was respectively 305.3 and 226.1 per 100,000 population in the community-led HIVST and SOC arms (RD 72.3, 95% CI -36.2 to 180.8; p = 0.18). In post hoc analysis, ART initiations in the 3-month post-intervention period were higher in the community-led HIVST arm than the SOC arm (RD 97.7, 95% CI 33.4 to 162.1; p = 0.004). HIVST uptake was 74.7% (2,956/3,960), with few adverse events (0.6%, 18/2,955) and at US$5.70 per HIVST kit distributed. The main limitations include the use of self-reported HIV testing outcomes and lack of baseline measurement for the primary outcome. CONCLUSIONS: In this study, we found that community-led HIVST was effective, safe, and affordable, with population impact and coverage rapidly realised at low cost. This approach could enable community HIV testing in high HIV prevalence settings and demonstrates potential for economies of scale and scope. TRIAL REGISTRATION: Clinicaltrials.gov NCT03541382.
Housing environment and early childhood development in sub-Saharan Africa: A cross-sectional analysis.
Gao Y, Zhang L, Kc A … +6 more , Wang Y, Zou S, Chen C, Huang Y, Mi X, Zhou H
PLoS Med · 2021 Apr · PMID 33872322 · Full text
BACKGROUND: The influence of the safety and security of environments on early childhood development (ECD) has been under-explored. Although housing might be linked to ECD by affecting a child's health and a parent's abil...
BACKGROUND: The influence of the safety and security of environments on early childhood development (ECD) has been under-explored. Although housing might be linked to ECD by affecting a child's health and a parent's ability to provide adequate care, only a few studies have examined this factor. We hypothesized that housing environment is associated with ECD in sub-Saharan Africa (SSA). METHODS AND FINDINGS: From 92,433 children aged 36 to 59 months who participated in Multiple Indicator Cluster Survey (MICS) in 20 SSA countries, 88,271 were tested for cognitive and social-emotional development using the Early Childhood Development Index (ECDI) questionnaire and were thus included in this cross-sectional analysis. Children's mean age was 47.2 months, and 49.8% were girls. Children were considered developmentally on track in a certain domain if they failed no more than 1 ECDI item in that domain. In each country, we used conditional logistic regression models to estimate the association between improved housing (housing with finished building materials, improved drinking water, improved sanitation facilities, and sufficient living area) and children's cognitive and social-emotional development, accounting for contextual effects and socioeconomic factors. Estimates from each country were pooled using random-effects meta-analyses. Subgroup analyses were conducted by the child's gender, maternal education, and household wealth quintiles. On-track cognitive development was associated with improved housing (odds ratio [OR] = 1.15, 95% CI 1.06 to 1.24, p < 0.001), improved drinking water (OR = 1.07, 95% CI 1.00 to 1.14, p = 0.046), improved sanitation facilities (OR = 1.15, 95% CI 1.03 to 1.28, p = 0.014), and sufficient living area (OR = 1.06, 95% CI 1.01 to 1.10, p = 0.018). On-track social-emotional development was associated with improved housing only in girls (OR = 1.14, 95% CI 1.04 to 1.25, p = 0.006). The main limitations of this study included the cross-sectional nature of the datasets and the use of the ECDI, which lacks sensitivity to measure ECD outcomes. CONCLUSIONS: In this study, we observed that improved housing was associated with on-track cognitive development and with on-track social-emotional development in girls. These findings suggest that housing improvement in SSA may be associated not only with benefits for children's physical health but also with broader aspects of healthy child development.
Dual therapy with an oral non-vitamin K antagonist and a P2Y12 inhibitor vs triple therapy with aspirin, a P2Y12 inhibitor and a vitamin K antagonist for the treatment of diabetes mellitus patients with co-existing atrial fibrillation following percutaneous coronary intervention: A meta-analysis.
Wang Q, Yang K
Medicine (Baltimore) · 2021 Apr · PMID 33847681 · Full text
BACKGROUND: In this analysis, we aimed to compare the efficacy and safety of dual therapy (DT) with a non-vitamin K oral anticoagulant (NOAC) and an adenosine diphosphate receptor antagonist (P2Y12 inhibitor) vs triple t...
BACKGROUND: In this analysis, we aimed to compare the efficacy and safety of dual therapy (DT) with a non-vitamin K oral anticoagulant (NOAC) and an adenosine diphosphate receptor antagonist (P2Y12 inhibitor) vs triple therapy (TT) with aspirin, a P2Y12 inhibitor and a vitamin K antagonist for the treatment of diabetes mellitus (DM) patients with co-existing atrial fibrillation (AF) following percutaneous coronary intervention (PCI). METHODS: Medical Literature Analysis and Retrieval System Online (MEDLINE), http://www.ClinicalTrials.gov, Excerpta Medical data BASE (EMBASE), Web of Science, Cochrane Central and Google Scholar were the searched databases. Studies that were randomized trials or observational studies comparing DT vs TT for the treatment of DM patients with co-existing AF following PCI were included in this analysis. The adverse cardiovascular outcomes and bleeding events were the endpoints. This meta-analysis was carried out by the RevMan version 5.4 software. Risk ratios (RR) with 95% confidence intervals (CI) were used to represent data and interpret the analysis. RESULTS: A total number of 4970 participants were included whereby 2456 participants were assigned to the DT group and 2514 participants were assigned to the TT group. The enrollment period varied from year 2006 to year 2018. Our current results showed that major adverse cardiac events (RR: 1.00, 95% CI: 0.84-1.20; P = .98), mortality (RR: 1.08, 95% CI: 0.78-1.48; P = .66), myocardial infarction (RR: 1.02, 95% CI: 0.74-1.42; P = .90), stroke (RR: 0.94, 95% CI: 0.53-1.67; P = .84) and stent thrombosis (RR: 1.09, 95% CI: 0.56-2.10; P = .80) were similar with DT versus TT in these patients. However, the risks for total major bleeding (RR: 0.66, 95% CI: 0.54-0.82; P = .0001), total minor bleeding (RR: 0.74, 95% CI: 0.64-0.85; P = .0001), Thrombolysis in Myocardial Infarction (TIMI) defined major bleeding (RR: 0.58, 95% CI: 0.35-0.95; P = .03), TIMI defined minor bleeding (RR: 0.62, 95% CI: 0.42-0.92; P = .02), intra-cranial bleeding (RR: 0.34, 95% CI: 0.13-0.95; P = .04) and major bleeding defined by the International Society on Thrombosis and Hemostasis (RR: 0.68, 95% CI: 0.51-0.90; P = .008) were significantly higher with TT. CONCLUSIONS: DT with a NOAC and a P2Y12 inhibitor was associated with significantly less bleeding events without increasing the adverse cardiovascular outcomes when compared to TT with aspirin, a P2Y12 inhibitor and a Vitamin K antagonist for the treatment of DM patients with co-existing AF following PCI. Hence, DT is comparable in efficacy, but safer compared to TT. This interesting hypothesis will have to be confirmed in future studies.
Evaluation of the Arabin cervical pessary for prevention of preterm birth in women with a twin pregnancy and short cervix (STOPPIT-2): An open-label randomised trial and updated meta-analysis.
Norman JE, Norrie J, MacLennan G … +15 more , Cooper D, Whyte S, Chowdhry S, Cunningham-Burley S, Mei XW, Smith JBE, Shennan A, Robson SC, Thornton S, Kilby MD, Marlow N, Stock SJ, Bennett PR, Denton J, STOPPIT-2 collaborative group
PLoS Med · 2021 Mar · PMID 33780463 · Full text
BACKGROUND: Preterm-labour-associated preterm birth is a common cause of perinatal mortality and morbidity in twin pregnancy. We aimed to test the hypothesis that the Arabin pessary would reduce preterm-labour-associated...
BACKGROUND: Preterm-labour-associated preterm birth is a common cause of perinatal mortality and morbidity in twin pregnancy. We aimed to test the hypothesis that the Arabin pessary would reduce preterm-labour-associated preterm birth by 40% or greater in women with a twin pregnancy and a short cervix. METHODS AND FINDINGS: We conducted an open-label randomised controlled trial in 57 hospital antenatal clinics in the UK and Europe. From 1 April 2015 to 14 February 2019, 2,228 women with a twin pregnancy underwent cervical length screening between 18 weeks 0 days and 20 weeks 6 days of gestation. In total, 503 women with cervical length ≤ 35 mm were randomly assigned to pessary in addition to standard care (n = 250, mean age 32.4 years, mean cervical length 29 mm, with pessary inserted in 230 women [92.0%]) or standard care alone (n = 253, mean age 32.7 years, mean cervical length 30 mm). The pessary was inserted before 21 completed weeks of gestation and removed at between 35 and 36 weeks or before birth if earlier. The primary obstetric outcome, spontaneous onset of labour and birth before 34 weeks 0 days of gestation, was present in 46/250 (18.4%) in the pessary group compared to 52/253 (20.6%) following standard care alone (adjusted odds ratio [aOR] 0.87 [95% CI 0.55-1.38], p = 0.54). The primary neonatal outcome-a composite of any of stillbirth, neonatal death, periventricular leukomalacia, early respiratory morbidity, intraventricular haemorrhage, necrotising enterocolitis, or proven sepsis, from birth to 28 days after the expected date of delivery-was present in 67/500 infants (13.4%) in the pessary group compared to 76/506 (15.0%) following standard care alone (aOR 0.86 [95% CI 0.54-1.36], p = 0.50). The positive and negative likelihood ratios of a short cervix (≤35 mm) to predict preterm birth before 34 weeks were 2.14 and 0.83, respectively. A meta-analysis of data from existing publications (4 studies, 313 women) and from STOPPIT-2 indicated that a cervical pessary does not reduce preterm birth before 34 weeks in women with a short cervix (risk ratio 0.74 [95% CI 0.50-1.11], p = 0.15). No women died in either arm of the study; 4.4% of babies in the Arabin pessary group and 5.5% of babies in the standard treatment group died in utero or in the neonatal period (p = 0.53). Study limitations include lack of power to exclude a smaller than 40% reduction in preterm labour associated preterm birth, and to be conclusive about subgroup analyses. CONCLUSIONS: These results led us to reject our hypothesis that the Arabin pessary would reduce the risk of the primary outcome by 40%. Smaller treatment effects cannot be ruled out. TRIAL REGISTRATION: ISRCTN Registry ISRCTN 02235181. ClinicalTrials.gov NCT02235181.
Efficacy and safety of postural intervention on prevention of deep venous thrombosis of lower extremity in postpartum women with pregnancy-induced hypertension: A protocol for systematic review and meta-analysis.
Chen J, Guo L, Li S … +1 more , Shi Y
Medicine (Baltimore) · 2021 Mar · PMID 33761653 · Full text
BACKGROUND: Deep venous thrombosis (DVT) is a relatively serious complication commonly seen in pregnant women, especially parturients with pregnancy-induced hypertension (PIH), whose incidence of DVT is higher. Because i...
BACKGROUND: Deep venous thrombosis (DVT) is a relatively serious complication commonly seen in pregnant women, especially parturients with pregnancy-induced hypertension (PIH), whose incidence of DVT is higher. Because it can lead to pulmonary embolism (PE) and endanger the lives of patients, it has been paid much attention in clinic. Nursing plays an important role in the prevention and treatment of DVT. Early posture intervention can prevent postpartum DVT in hypertensive pregnant women, which has certain clinical value, but there is no evidence of evidence-based medicine. This study aims to systematically study the effectiveness and safety of postural intervention on prevention of deep venous thrombosis of lower extremity in postpartum women with PIH. METHODS: Use the computer to retrieve the English databases (PubMed, Embase, Web of Science, the Cochrane Library) and the Chinese databases (China Knowledge Network, Wanfang, Weipu, China Biomedical Database), in addition to the manual retrieval of Baidu academic, Google academic, from the construction of database to December 2020, for randomized controlled clinical studies of postural intervention on prevention of deep venous thrombosis of lower extremity in postpartum women with PIH. Two researchers independently extracted the data and evaluated the quality of the included research, and used RevMan5.3 software to do meta-analyze of the included literature. RESULTS: This study assessed the efficacy and safety of potential intervention on prevention of deep venous thrombosis of lower extremities with lower extremity hypertension by mean velocity of femoral venous flow in the lower extremities, lower extremity skin status, swelling level, and pain condition, lower extremity deep venous thrombosis rate, and incidence of pulmonary embolism. CONCLUSION: This study will provide reliable evidence-based evidence for the clinical application of postural intervention on prevention of deep venous of lower extremity in Postpartum women with PIH. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/4NPKW.
Acupuncture for HIV-associated distal symmetric peripheral neuropathy: A protocol for systematic review and meta-analysis.
Gao N, Guo Y, Wang W
Medicine (Baltimore) · 2021 Mar · PMID 33725916 · Full text
BACKGROUND: Human immunodeficiency virus (HIV)-associated distal symmetric peripheral neuropathy (DSPN) is one of the most frequent neurological complications of HIV infection, and causes pain and dysaesthesias in millio...
BACKGROUND: Human immunodeficiency virus (HIV)-associated distal symmetric peripheral neuropathy (DSPN) is one of the most frequent neurological complications of HIV infection, and causes pain and dysaesthesias in millions globally. Many individuals with this infection report using acupuncture to manage their symptoms, but evidence supporting the use of acupuncture is limited. This systematic review will assess the effectiveness and safety of acupuncture for patients with HIV-associated DSPN. METHODS: Databases including MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Scopus, Web of science, AMED (Allied and Complementary Medicine), the Chinese Biomedical Literature Database, the China National Knowledge Infrastructure, Wanfang Database, VIP Database and clinical trials registers (the WHO International Clinical Trials Registry Platform portal and www.ClinicalTrials.gov) will be electronically searched from inception to December 1, 2020. All randomized controlled trials in English or Chinese without restriction on publication status will be included. Selection of studies, extraction of data, and assessment of studies quality will be independently performed by 2 reviewers. The primary outcome measure will be the change in pain intensity assessed by validated scales. Secondary outcomes include change in neurologic summary scores, quality of life, physical function evaluated by admitted tools, and adverse events related to acupuncture reported in the included trials. If possible, a meta-analysis will be conducted to provide an estimate of the pooled treatment effect using Review Manager 5.3 statistical software. Otherwise, qualitative descriptive analysis will be given. The results will be presented as the risk ratio for binary data and the mean difference (MD) or standardized MD for continuous data. RESULTS: The results of the systematic review will be disseminated via publication in a peer-reviewed journal and presented at a relevant conference. CONCLUSION: This review will be the first review entirely focused on assessing the effectiveness and safety of acupuncture for HIV-associated DSPN. PROSPERO REGISTRATION NUMBER: CRD42020210994.
Efficacy and safety of acupuncture treatment as an adjunctive therapy after knee replacement: Single-center, pragmatic, randomized, assessor blinded, pilot study.
Park TY, Kim HJ, Lee JH … +5 more , Sunwoo YY, Do KS, Han SN, Song YK, Chae DS
Medicine (Baltimore) · 2021 Mar · PMID 33725856 · Full text
INTRODUCTION: Total knee replacement (TKR) is a surgical procedure that is being increasingly performed as a result of population aging and the increased average human life expectancy in South Korea. Consistent with the...
INTRODUCTION: Total knee replacement (TKR) is a surgical procedure that is being increasingly performed as a result of population aging and the increased average human life expectancy in South Korea. Consistent with the growing number of TKR procedures, the number of patients seeking acupuncture for relief from adverse effects, effective pain management, and the enhancement of rehabilitative therapy effects and bodily function after TKR has also been increasing. Thus, an objective examination of the evidence regarding the safety and efficacy of acupuncture treatments is essential. The aim of this study is to verify the hypothesis that the concurrent use of acupuncture treatment and usual care after TKR is more effective, safe, and cost-effective for the relief of TKR symptoms than usual care therapy alone. METHODS/DESIGN: This is an open-label, parallel, assessor-blinded randomized controlled trial that includes 50 patients with TKR. After screening the patients and receiving informed consent, the patients are divided into two groups (usual care + acupuncture group and usual care group); the patients will then undergo TKR surgery and will be hospitalized for 2 weeks. The patients will receive a total of 8 acupuncture treatments over 2 weeks after surgery and will be followed up at 3, 4, and 12 weeks after the end of the intervention. The primary outcome is assessed using the Korean version of the Western Ontario and McMaster Universities Arthritis Index (K-WOMAC), and the secondary outcome is measured using the Numerical Rating Scale (NRS), Risk of Fall, and Range of Motion (ROM). Moreover, the cost per quality-adjusted life years (QALYs) is adopted as a primary economic outcome for economic evaluation, and the cost per NRS is adopted as a secondary economic outcome. ETHICS AND DISSEMINATION: This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS17ENSS0063). We intend to submit the results to a peer-reviewed journal and/or conferences. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03633097.
Effect of Chinese herbal medicine for patients with benign thyroid nodules in adults: A protocol for systematic review and meta-analysis.
Ouyang S, Li W, Yu P … +3 more , Li H, Cai H, Wu J
Medicine (Baltimore) · 2021 Feb · PMID 33663069 · Full text
BACKGROUND: Thyroid nodules (TN) are discrete lesions within the thyroid gland and are a common clinical problem detected in 19% to 68% of people. TN are more common as age increases and occur more frequently in women. T...
BACKGROUND: Thyroid nodules (TN) are discrete lesions within the thyroid gland and are a common clinical problem detected in 19% to 68% of people. TN are more common as age increases and occur more frequently in women. TN can cause pressure symptoms, cosmetic complaints, and thyroid dysfunction. Treatment for benign thyroid nodules includes thyroid hormone therapy, surgery, radioiodine treatment, percutaneous ethanol injection therapy, and laser or radiofrequency treatment to shrink nodules. In China and many other countries, doctors use Chinese herbal medicines (CHM) to treat TN. However, systematic review and meta-analysis has not been found to assess the effects and safety of CHM in curing TN at present. Hence, the systematic review is conducted to scientifically and methodically evaluate the value of its effectiveness and safety of CHM on TN. METHODS: Literatures related to CHM for TN from the establishment of the database to November 2020 will be retrieved from the following databases: PubMed, Excerpta Medica Database (EMBASE), MEDLINE, Web of Science, Cochrane Library, SpringerLink, WHO International Clinical Trials Registry Platform (ICTRP), Wanfang Database, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), and Chinese Scientific Journal Database (VIP). There are no language restrictions for retrieving literatures. Case reports, animal studies, editorials, expert opinions, reviews without original data, and studies on pediatric population were excluded. Eligible randomized clinical trials (RCTs) evaluating the effectiveness and safety of CHM in TN patients will be put in the study including nodule volume reduction ≥50%, pressure symptoms, cosmetic complaints, quality of life, and adverse events. By scanning the titles, abstracts and full texts, 2 reviewers will independently select studies, extract data, and assess the quality of study. Meta-analysis of RCTs will be conducted using Review Manager 5.1 software. The results will be presented as risk ratio for dichotomous data, and standardized or weighted mean difference for continuous data. RESULT: This study will provide high-quality available evidence for the treatment of TN with CHM based on nodule volume reduction ≥50%, pressure symptoms, cosmetic complaints, quality of life, and adverse events. CONCLUSION: The systematic review will to evaluate the efficacy of CHM in treating benign thyroid nodules in adults and provide evidence for clinicians. INPLASY REGISTRATION NUMBER: INPLASY2020120093.
Single- or dual-antiplatelet therapy after transcatheter aortic valve replacement: A protocol of systematic review and meta-analysis.
Li H, Wang Y, Li L … +1 more , Dan B
Medicine (Baltimore) · 2021 Feb · PMID 33578550 · Full text
BACKGROUND: The evidence related to bleeding and thromboembolic events after transcatheter aortic valve replacement (TAVR) compared single antiplatelet therapy (SAPT) with dual antiplatelet therapy (DAPT) treatment are i...
BACKGROUND: The evidence related to bleeding and thromboembolic events after transcatheter aortic valve replacement (TAVR) compared single antiplatelet therapy (SAPT) with dual antiplatelet therapy (DAPT) treatment are inconsistent. Moreover, there are some limitations such as small sample size and the risk of bias in existing studies. We will conduct a comprehensive systematic review and meta-analysis to explore the safety and efficacy of SAPT or DAPT after TAVR. METHODS: A comprehensive literature search of PubMed, EMBASE, The Cochrane Library, Cochrane Central Register of Controlled Trials will be searched to retrieve studies involving SAPT versus DAPT after TAVR. Two investigators will independently select studies, extract data, and assess the quality of the included study. Any disagreement will be resolved by the third investigator. The study will use a random-effects model to pool the results of all studies and use the relative risk and 95% confidence intervals to summarize individual trial outcomes and estimate pooled effect. The study will use the Grading of Recommendations Assessment, Development, and Evaluation to assess the certainty of evidence. RESULTS: This study will provide high-quality evidence for treatment of TAVR in terms of effectiveness and safety. CONCLUSION: This systematic review aims to provide evidence for treatment of TAVR in different antiplatelet therapies. REGISTRATION: The systematic review and meta-analysis is registered in the OSF REGISTRIES (10.17605/OSF.IO/Q42TE) international prospective register.
Acupuncture for behavioral and psychological symptoms of dementia: A protocol of systematic review.
Kwon CY, Lee B
Medicine (Baltimore) · 2021 Feb · PMID 33578529 · Full text
BACKGROUND: Dementia is a major mental health problem worldwide, and an optimal anti-dementia drug that could modify its core symptoms has not been developed yet. Behavioral and psychological symptoms of dementia (BPSD),...
BACKGROUND: Dementia is a major mental health problem worldwide, and an optimal anti-dementia drug that could modify its core symptoms has not been developed yet. Behavioral and psychological symptoms of dementia (BPSD), an important clinical manifestation of dementia, is closely related to disease burden, caregiver burden, and consequent social burden. In general, many experts and international guidelines prefer non-pharmacological interventions, including psychosocial intervention, and complementary and integrative medicine in the management of BPSD. However, in clinical settings, psychotropic drugs are frequently used; therefore, the need to establish and actively use effective non-pharmacological interventions is emphasized. Therefore, in this systematic review, we will evaluate the effectiveness and safety of acupuncture, a promising non-pharmacological complementary and integrative medicine, for BPSD. METHODS AND ANALYSIS: A comprehensive search will be conducted in 13 electronic medical databases. Regardless of its design, original clinical studies, such as randomized controlled clinical trials, nonrandomized controlled clinical trials, and before-after studies, will be included to assess the beneficial effects and safety of acupuncture on BPSD. The severity of BPSD symptoms assessed by the validated tool will be considered as a primary outcome. The secondary outcome included the total effective rate, daily living activities and quality of life of patients, burden and quality of life of caregiver, placement in a long-term care facility from home, and safety data. The study selection, data extraction, and quality assessment process were performed by 2 independent researchers. The methodological quality of the included studies will be assessed using validated tools according to its design, such as the Cochrane Collaboration's risk of bias tool. RevMan version 5.3 will be used to perform the meta-analysis, with mean differences for continuous outcomes and risk ratio for binary outcomes, and 95% confidence intervals. A fixed- or random-effects model will be used according to the heterogeneity and number of included studies. ETHICS AND DISSEMINATION: As this protocol is for a systematic review, ethical approval is not required. The results of the systematic review will be disseminated by the publication of a manuscript in a peer-reviewed journal or presentation at a relevant conference. REGISTRATION NUMBER: OSF (URL: https://osf.io/hu5ac), PROSPERO (CRD42020211005) (URL: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020211005).
Who should be prioritized for COVID-19 vaccination in China? A descriptive study.
Yang J, Zheng W, Shi H … +10 more , Yan X, Dong K, You Q, Zhong G, Gong H, Chen Z, Jit M, Viboud C, Ajelli M, Yu H
BMC Med · 2021 Feb · PMID 33563270 · Full text
BACKGROUND: All countries are facing decisions about which population groups to prioritize for access to COVID-19 vaccination after the first vaccine products have been licensed, at which time supply shortages are inevit...
BACKGROUND: All countries are facing decisions about which population groups to prioritize for access to COVID-19 vaccination after the first vaccine products have been licensed, at which time supply shortages are inevitable. Our objective is to define the key target populations, their size, and priority for a COVID-19 vaccination program in the context of China. METHODS: On the basis of utilitarian and egalitarian principles, we define and estimate the size of tiered target population groups for a phased introduction of COVID-19 vaccination, considering evolving goals as vaccine supplies increase, detailed information on the risk of illness and transmission, and past experience with vaccination during the 2009 influenza pandemic. Using publicly available data, we estimated the size of target population groups, and the number of days needed to vaccinate 70% of the target population. Sensitivity analyses considered higher vaccine coverages and scaled up vaccine delivery relative to the 2009 pandemic. RESULTS: Essential workers, including staff in the healthcare, law enforcement, security, nursing homes, social welfare institutes, community services, energy, food and transportation sectors, and overseas workers/students (49.7 million) could be prioritized for vaccination to maintain essential services in the early phase of a vaccination program. Subsequently, older adults, individuals with underlying health conditions and pregnant women (563.6 million) could be targeted for vaccination to reduce the number of individuals with severe COVID-19 outcomes, including hospitalizations, critical care admissions, and deaths. In later stages, the vaccination program could be further extended to target adults without underlying health conditions and children (784.8 million), in order to reduce symptomatic infections and/or to stop virus transmission. Given 10 million doses administered per day, and a two-dose vaccination schedule, it would take 1 week to vaccinate essential workers but likely up to 7 months to vaccinate 70% of the overall population. CONCLUSIONS: The proposed framework is general but could assist Chinese policy-makers in the design of a vaccination program. Additionally, this exercise could be generalized to inform other national and regional strategies for use of COVID-19 vaccines, especially in low- and middle-income countries.
Acupuncture combined with moxibustion for insomnia after stroke: A protocol for systematic review and meta analysis.
Sun J, Zuo Z, Song R … +2 more , Bao X, Zhu M
Medicine (Baltimore) · 2021 Jan · PMID 33546019 · Full text
BACKGROUND: Stroke is the main cause of death and disability in the world and insomnia is a common complication of stroke patients. Insomnia will not only seriously affect the prognosis and quality of life of patients wi...
BACKGROUND: Stroke is the main cause of death and disability in the world and insomnia is a common complication of stroke patients. Insomnia will not only seriously affect the prognosis and quality of life of patients with stroke, but even cause the recurrence of stroke. Many studies have proved that acupuncture and moxibustion can effectively improve insomnia symptoms. This study will systematically evaluate the effectiveness and safety of acupuncture combined with moxibustion in treating insomnia after stroke. METHODS: The following 8 databases will be searched from the inception to October 31, 2020, including China National Knowledge Infrastructure Database (CNKI), Chinese Scientific Journal Database (VIP database), China Biomedical Literature Database (CBM), Wanfang Data Chinese Database, PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL), Allied and Alternative Medicine Database (AMED), Excerpt Medica Database (Embase). We will also search for ongoing trials from the World Health Organization International Clinical Trial Registration Platform search portal, Chinese Clinical Trial Register, Clinical trials.gov. In addition, the reference lists of studies meeting the inclusion criteria will also be searched for achieving the comprehensive retrieval to the maximum. All randomized controlled trials of acupuncture and moxibustion in treating insomnia after stroke will be included. Two reviewers will conduct literature screening, data extraction, and quality evaluation respectively. The main outcome is the Pittsburgh sleep quality index (PSQI), and the secondary outcomes include clinical efficacy, quality of life, and safety. RevMan V.5.4.1 will be used for meta-analysis. We will express the results as risk ratio (RR) with 95% confidence intervals (CIs) for dichotomous data and mean difference (MD) or standard mean difference (SMD) 95% CIs for continuous data. RESULTS: This study will provide a comprehensive review of the available evidence of acupuncture combined with moxibustion in treating insomnia after stroke. CONCLUSION: The conclusion of our study will provide the updated evidence to judge the effectiveness and safety of acupuncture combined with moxibustion for the treatment of insomnia after stroke. TRIAL REGISTRATION NUMBER: PROSPERO CRD42020216720.
Calcineurin inhibitors in the treatment of primary focal segmental glomerulosclerosis: A protocol of systematic review and meta-analysis of randomized controlled trials.
Xue G, Wang X, Li S … +1 more , Dai E
Medicine (Baltimore) · 2021 Jan · PMID 33530282 · Full text
BACKGROUND: Evidence suggesting a role for including calcineurin inhibitors(CNIs) in early therapy remains limited for low quality and mainly based on small observation cohort study. We will conduct a systematic reviews...
BACKGROUND: Evidence suggesting a role for including calcineurin inhibitors(CNIs) in early therapy remains limited for low quality and mainly based on small observation cohort study. We will conduct a systematic reviews to explore the effect and adverse effect of calcineurin inhibitors compared with other interventions in the treatment of primary focal segmental glomerulosclerosis (FSGS). METHODS: A comprehensive literature search of MEDLINE (through PubMed), EMBASE, The Cochrane Library, Cochrane Central Register of Controlled Trials (CENTRAL) will be conducted. Two investigators will independently select studies, extract data and assess the quality of the included study. Extracted information will include study characteristics, the contents of included randomized controlled trials, outcomes, the quality of randomized controlled trials and etc. A risk of bias tool will be used to assess the methodological quality. Any disagreement will be resolved by the third investigator. There is no requirement of ethical approval and informed consent. RESULTS: This study will provide high-quality evidence for treatment of FSGS in terms of effectiveness and safety. CONCLUSION: This systematic review aims to provide evidence for treatment of FSGS in different CNIs. REGISTRATION: The systematic review and meta-analysis is registered in the OSF REGISTERS (10.17605/OSF.IO/3B7DE) international prospective register of systematic review.
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