The International Journal Of Risk & Safety In Medicine[JOURNAL]
Sun
200 papers
A systematic review and meta-analysis for Chinese herbal medicine Duhuo Jisheng decoction in treatment of lumbar disc herniation: A protocol for a systematic review.
Sun K, Huang F, Qi B … +7 more , Yin H, Tang B, Yang B, Chen L, Zhuang M, Wei X, Zhu L
Medicine (Baltimore) · 2020 Feb · PMID 32118755 · Full text
BACKGROUND: Lumbar disc herniation (LDH) is 1 of the most common diseases in orthopedics, which seriously affects people's daily life and brings a heavy burden on society and families. Chinese herbal medicine has been us...
BACKGROUND: Lumbar disc herniation (LDH) is 1 of the most common diseases in orthopedics, which seriously affects people's daily life and brings a heavy burden on society and families. Chinese herbal medicine has been used in clinical practice for a long time and Duhuo Jisheng Decoction (DHJSD) is believed to help alleviate the symptoms of LDH. This systematic review aims to collect evidences from randomized clinical trials and evaluate the efficacy of DHJSD on LDH in order to provide a reference for clinicians and researchers. METHODS: We will comprehensively search the 8 electronic databases until December 2019 to identify related randomized controlled trials, including 4 foreign databases (PubMed, MEDLINE, EMBASE, Cochrane Library) and 4 Chinese databases (China National Knowledge Infrastructure Database, VIP Database, Wanfang Database and China Biology Medicine disc). The data of the World Health Organization International Clinical Trial Registry Platform and the Chinese Clinical Trial Registry also will be searched. The primary outcomes are Japanese Orthopaedic Association scores and visual analog scale scores. The risk of bias will be assessed using the Cochrane Collaboration tool. RevMan (V.5.3) software will be used for meta-analysis. RESULTS: This study will report the results of DHJSD for the treatment of LDH from the literature screening, the basic information of the included studies, the risk of bias of the included studies, treatment effects, safety, and so on. CONCLUSION: This systematic review will evaluate the effectiveness and safety of DHJSD for the treatment of LDH and provide the latest evidence for its clinical application. ETHICS AND DISSEMINATION: This is a literature-based study, therefore it does not require ethical approval. PROSPERO REGISTRATION NUMBER: CRD42019147302.
The short-term and long-term outcomes of transcatheter or surgical aortic valve replacement in elderly patients: A protocol for a systematic review.
Lei X, Wei Z, Liu S … +2 more , Liang F, Song B
Medicine (Baltimore) · 2020 Feb · PMID 32118752 · Full text
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an essential alternate option for people suffering from aortic stenosis. However, the efficacy and safety of TAVR for elderly population (aged over 80...
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an essential alternate option for people suffering from aortic stenosis. However, the efficacy and safety of TAVR for elderly population (aged over 80 years) is still unclear. METHODS: We plan to perform a systematic review and meta-analysis of clinical controlled trials and propensity-match cohort studies to evaluate the short- and long-term outcomes in elderly aortic stenosis patients who undergo a transcatheter or surgical aortic valve replacement. We will search PubMed, EMBASE, and Cochrane Library using a comprehensive strategy. The related conference proceedings and reference lists of the included studies will also be checked to identify additional studies. Two reviewers will screen retrieved records, extract information, and assess the risk of bias independently. STATA software will be used to conduct data synthesis. There is no requirement of ethical approval and informed consent. RESULTS: This study will be submitted to a peer-reviewed journal for publication. CONCLUSION: This is the first systematic assessment of TAVR for elderly patients with aortic stenosis. We hope it will provide a relatively comprehensive reference for clinical practice and future relevant clinical trials. ETHICS AND DISSEMINATION: Ethics approval and patient consent are not required as this study is a systematic review and meta-analysis. PROSPERO REGISTRATION NUMBER: CRD42019140857. STUDY PROTOCOL REGISTRY: The protocol has been registered in PROSPERO, which is an International Prospective Register of Systematic Reviews. The registration number is CRD42019140857.
The effectiveness of frequent antibiotic use in reducing the risk of infection-related hospital admissions: results from two large population-based cohorts.
van Staa TP, Palin V, Li Y … +4 more , Welfare W, Felton TW, Dark P, Ashcroft DM
BMC Med · 2020 Mar · PMID 32114981 · Full text
BACKGROUND: Previous research reported that individuals prescribed antibiotics frequently develop antimicrobial resistance. The objective of this study was to evaluate whether frequent antibiotic use is associated with r...
BACKGROUND: Previous research reported that individuals prescribed antibiotics frequently develop antimicrobial resistance. The objective of this study was to evaluate whether frequent antibiotic use is associated with reduced hospital admissions for infection-related complications. METHODS: Population-based cohort study analysing electronic health records from primary care linked to hospital admission records. The study population included patients prescribed a systemic antibiotic, recent record of selected infections and no history of chronic obstructive pulmonary disease. Propensity-matched cohorts were identified based on quintiles of prior antibiotic use in 3 years before. RESULTS: A total of 1.8 million patients were included. Repeated antibiotic use was frequent. The highest rates of hospital admissions for infection-related complications were observed shortly after antibiotic start in all prior exposure quintiles. For patients with limited prior antibiotic use, rates then dropped quickly and substantially. In contrast, reductions over time were substantially less in patients with frequent prior antibiotic use, with rates remaining elevated over the following 6 months. In patients without comorbidity comparing the highest to lowest prior exposure quintiles in the Clinical Practice Research Databank, the IRRs were 1.18 [95% CI 0.90-1.55] in the first 3 days after prescription, 1.44 [95% CI 1.14-1.81] in the days 4-30 after and 3.22 [95% CI 2.29-4.53] in the 3-6 months after. CONCLUSIONS: Repeated courses of antibiotics, although common practice, may have limited benefit and indicator of adverse outcomes. A potential mechanism is that antibiotics may cause dysbiosis (perturbations of intestinal microbiota), contributing to colonization with resistant bacteria. Antibiotics should be used judiciously and only periodically unless indicated. Antimicrobial stewardship should include activities focusing on the substantive number of patients who repeatedly but intermittently get antibiotics.
Use of smoking cessation pharmacotherapies during pregnancy is not associated with increased risk of adverse pregnancy outcomes: a population-based cohort study.
Tran DT, Preen DB, Einarsdottir K … +5 more , Kemp-Casey A, Randall D, Jorm LR, Choi SKY, Havard A
BMC Med · 2020 Feb · PMID 32019533 · Full text
BACKGROUND: Varenicline, bupropion and nicotine replacement therapy (NRT) are three effective pharmacotherapies for smoking cessation, but data about their safety in pregnancy are limited. We assessed the risk of adverse...
BACKGROUND: Varenicline, bupropion and nicotine replacement therapy (NRT) are three effective pharmacotherapies for smoking cessation, but data about their safety in pregnancy are limited. We assessed the risk of adverse perinatal outcomes and major congenital anomalies associated with the use of these therapies in pregnancy in Australia. METHODS: Perinatal data for 1,017,731 deliveries (2004 to 2012) in New South Wales and Western Australia were linked to pharmaceutical dispensing, hospital admission and death records. We identified 97,875 women who smoked during pregnancy; of those, 233, 330 and 1057 were exposed to bupropion, NRT and varenicline in pregnancy, respectively. Propensity scores were used to match exposed women to those who were unexposed to any smoking therapy (1:10 ratio). Propensity scores and gestational age at exposure were used to match varenicline-exposed to NRT-exposed women (1:1 ratio). Time-dependent Cox proportional hazards models estimated hazard ratios (HR) with 95% confidence intervals (95% CI) for any adverse perinatal event (a composite of 10 unfavourable maternal and neonatal outcomes) and any major congenital anomaly. RESULTS: The risk of any adverse perinatal event was not significantly different between bupropion-exposed and unexposed women (39.2% versus 39.3%, HR 0.93, 95% CI 0.73-1.19) and between NRT-exposed and unexposed women (44.8% vs 46.3%, HR 1.02, 95% CI 0.84-1.23), but it was significantly lower in women exposed to varenicline (36.9% vs 40.1%, HR 0.86, 95% CI 0.77-0.97). Varenicline-exposed infants were less likely than unexposed infants to be born premature (6.5% vs 8.9%, HR 0.72, 95% CI 0.56-0.92), be small for gestational age (11.4% vs 15.4%, HR 0.68, 95% CI 0.56-0.83) and have severe neonatal complications (6.6% vs 8.2%, HR 0.74, 95% CI 0.57-0.96). Among infants exposed to varenicline in the first trimester, 2.9% had a major congenital anomaly (3.5% in unexposed infants, HR 0.91, 95% CI 0.72-1.15). Varenicline-exposed women were less likely than NRT-exposed women to have an adverse perinatal event (38.7% vs 51.4%, HR 0.58, 95% CI 0.33-1.05). CONCLUSIONS: Pregnancy exposure to smoking cessation pharmacotherapies does not appear to be associated with an increased risk of adverse birth outcomes. Lower risk of adverse birth outcomes in varenicline-exposed pregnancies is inconsistent with recommendations that NRT be used in preference to varenicline.
Effects of exercise therapy for pregnancy-related low back pain and pelvic pain: A protocol for systematic review and meta-analysis.
Hu X, Ma M, Zhao X … +4 more , Sun W, Liu Y, Zheng Z, Xu L
Medicine (Baltimore) · 2020 Jan · PMID 32011431 · Full text
BACKGROUND: Pregnancy-related low back pain (PLPB) and pelvic pain (PP) are common in pregnancy. In spite of its high prevalence rate, treatment of the disorder is a challenging topic. Women commonly utilize complementar...
BACKGROUND: Pregnancy-related low back pain (PLPB) and pelvic pain (PP) are common in pregnancy. In spite of its high prevalence rate, treatment of the disorder is a challenging topic. Women commonly utilize complementary exercise therapies such as yoga, motor control exercises, breathing exercises, core stability exercise, pelvic stability exercise, and so on to manage their symptoms. However, it is currently unknown whether exercise produces more beneficial effects than other treatment in patients with PLPB and PP. The aim of this study is to explore the therapeutic effect of exercise for pregnancy-related low back pain and PP. METHODS: This review will only include randomized controlled trials. Published articles from July 1999 to July 2019 will be identified using electronic searches. Search strategy will be performed in 3 English databases, 1 Chinese database, and the World Health Organization International Clinical Trials Registry Platform. Two reviewers will screen, select studies, extract data, and assess quality independently. The methodological quality including the risk of bias of the included studies will be evaluated using a modified assessment form, which is based on Cochrane assessment tool and Physiotherapy Evidence Database scale. Review Manager Software (Revman5.3) will be used for heterogeneity assessment, generating funnel-plots, data synthesis, subgroup analysis, and sensitivity analysis. We will use GRADE system to evaluate the quality of our evidence. RESULTS: We will provide some more practical and targeted results investigating the effect of exercise therapy (ET) for PLPB and PP in the current meta-analysis. Meanwhile, we will ascertain study progress of ET for PLPB and PP and find out defects or inadequacies of previous studies, so that future researchers could get beneficial guidance for more rigorous study. CONCLUSION: The stronger evidence about PLPB and PPs rehabilitative effect and safety will be provided for clinicians and policymakers. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD 42017075099.
Acupuncture for symptomatic rotator cuff disease: Protocol for a systematic review and meta-analysis.
Choi S, Kim KH
Medicine (Baltimore) · 2020 Jan · PMID 31914084 · Full text
BACKGROUND: Rotator cuff disease (RCD) consists of subacromial impingement syndrome, rotator cuff tendinopathy or tendinitis, partial or full rotator cuff tear, calcific tendinitis, and subacromial bursitis. Acupuncture...
BACKGROUND: Rotator cuff disease (RCD) consists of subacromial impingement syndrome, rotator cuff tendinopathy or tendinitis, partial or full rotator cuff tear, calcific tendinitis, and subacromial bursitis. Acupuncture has been suggested as a meaningful nonsurgical intervention for managing shoulder pain and dysfunction. However, previous reviews have not completely addressed the role of acupuncture in the management of RCDs. The objective of this systematic review is to evaluate the effectiveness and safety of acupuncture for managing symptoms in patients with RCD. METHODS: We will search the following databases from their inception to November 30, 2019: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine (AMED), Physiotherapy Evidence Database (PEDro), 3 Chinese databases (China Academic Journal Full-text Database (CAJ), China Doctoral Dissertations Full-text database and China Masters' Thesis Full-text Database), 6 Korean databases (Korean studies Information Service System (KISS), National Digital Science Library (NDSL), Research Information Sharing Service (RISS), Korean Medical Database (KMBASE), Korea Institute of Science and Technology Information (KISTI), Oriental Medicine Advanced Searching Integrated System (OASIS)), and 3 trial registries (ClinicalTrials.gov, International Standard Randomized Controlled Trials Number (ISRCTN) Registry, WHO International Clinical Trials Registry Platform (ICTRP)). We will include randomized controlled trials of acupuncture for RCD. There will be no restrictions related to setting or location. The primary outcome is pain intensity and shoulder dysfunction measured on validated scales within 12 weeks. Quality assessment will be performed using the Cochrane risk of bias tool. Dichotomous outcomes will be presented as risk ratios (RR), and continuous outcomes will be presented as weighted or standardized mean differences (SMD). Each outcome will be calculated with 95% confidence intervals. DISCUSSION: The updated evidence that would be provided by this review will offer useful information for patients and practitioners, and also have implications for future studies and the development of clinical practice guidelines of RCD.Registration: Open Science Framework (OSF) Preregistration. 2019, December 5. osf.io/n2e6t.
Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed low-risk subset B rhabdomyosarcoma: A study protocol.
Miyachi M, Tsuchiya K, Hosono A … +6 more , Ogawa A, Koh K, Kikuta A, Hara J, Teramukai S, Hosoi H
Medicine (Baltimore) · 2019 Dec · PMID 31876708 · Full text
BACKGROUND: Approximately 80% to 90% of patients with low-risk rhabdomyosarcoma can be cured. However, cured patients often face long-term complications associated with the treatment. An important factor in the treatment...
BACKGROUND: Approximately 80% to 90% of patients with low-risk rhabdomyosarcoma can be cured. However, cured patients often face long-term complications associated with the treatment. An important factor in the treatment plan is the dose of cyclophosphamide administered because the dose can have both acute and long-term side effects. It is therefore essential to investigate whether the dose can be reduced without a negative effect on treatment outcome. The ARST0331 trial revealed that drastically reducing the cyclophosphamide dose to 4.8 g/m negatively affected treatment outcomes. The current study aims to determine whether reducing the cyclophosphamide dose to 10.8 g/m while introducing a new drug, irinotecan, can prevent the negative effect on treatment outcome. We also aim to investigate whether the reduced cyclophosphamide dose results in a decrease in infertility, one of the long-term complications of this treatment. METHODS: The subjects are patients with stage 1 group III rhabdomyosarcoma (excluding those with orbital group III N0 and NX) or patients with stage 3 group I and II low-risk subset B embryonal rhabdomyosarcoma who will alternately undergo VAC 1.2 treatment (vincristine, actinomycin D, cyclophosphamide 1.2 g/m) and VI treatment (vincristine, irinotecan). The effectiveness and safety of this treatment regimen will be assessed. Data will be presented at international conferences and will be published in peer-reviewed journals. DISCUSSION: This study is significant because it aims to establish that the use of irinotecan in patients with low-risk subset B embryonal rhabdomyosarcoma (aged 30 or younger) allows the dose of cyclophosphamide to be reduced and is associated with few short-term adverse effects and long-term complications. The open-label and single-arm design of this study may be a limitation. TRIAL REGISTRATION AND ETHICAL APPROVAL: The trial registration number is jRCTs051180200 (Japan Registry of Clinical Trials). The study protocol was approved by the institutional review board at each of the participating centers and the data will be presented at international conferences and published in peer-reviewed journals.
Prescription of benzodiazepines, z-drugs, and gabapentinoids and mortality risk in people receiving opioid agonist treatment: Observational study based on the UK Clinical Practice Research Datalink and Office for National Statistics death records.
Macleod J, Steer C, Tilling K … +5 more , Cornish R, Marsden J, Millar T, Strang J, Hickman M
PLoS Med · 2019 Nov · PMID 31770388 · Full text
BACKGROUND: Patients with opioid dependency prescribed opioid agonist treatment (OAT) may also be prescribed sedative drugs. This may increase mortality risk but may also increase treatment duration, with overall benefit...
BACKGROUND: Patients with opioid dependency prescribed opioid agonist treatment (OAT) may also be prescribed sedative drugs. This may increase mortality risk but may also increase treatment duration, with overall benefit. We hypothesised that prescription of benzodiazepines in patients receiving OAT would increase risk of mortality overall, irrespective of any increased treatment duration. METHODS AND FINDINGS: Data on 12,118 patients aged 15-64 years prescribed OAT between 1998 and 2014 were extracted from the Clinical Practice Research Datalink. Data from the Office for National Statistics on whether patients had died and, if so, their cause of death were available for 7,016 of these patients. We identified episodes of prescription of benzodiazepines, z-drugs, and gabapentinoids and used linear regression and Cox proportional hazards models to assess the associations of co-prescription (prescribed during OAT and up to 12 months post-treatment) and concurrent prescription (prescribed during OAT) with treatment duration and mortality. We examined all-cause mortality (ACM), drug-related poisoning (DRP) mortality, and mortality not attributable to DRP (non-DRP). Models included potential confounding factors. In 36,126 person-years of follow-up there were 657 deaths and 29,540 OAT episodes, of which 42% involved benzodiazepine co-prescription and 29% concurrent prescription (for z-drugs these respective proportions were 20% and 11%, and for gabapentinoids 8% and 5%). Concurrent prescription of benzodiazepines was associated with increased duration of methadone treatment (adjusted mean duration of treatment episode 466 days [95% CI 450 to 483] compared to 286 days [95% CI 275 to 297]). Benzodiazepine co-prescription was associated with increased risk of DRP (adjusted HR 2.96 [95% CI 1.97 to 4.43], p < 0.001), with evidence of a dose-response effect, but showed little evidence of an association with non-DRP (adjusted HR 0.91 [95% CI 0.66 to 1.25], p = 0.549). Co-prescription of z-drugs showed evidence of an association with increased risk of DRP (adjusted HR 2.75 [95% CI 1.57 to 4.83], p < 0.001) but little evidence of an association with non-DRP (adjusted HR 0.79 [95% CI 0.49 to 1.28], p = 0.342). There was no evidence of an association of gabapentinoid co-prescription with DRP (HR 1.54 [95% CI 0.60 to 3.98], p = 0.373) but evidence of an association with increased non-DRP (HR 1.83 [95% CI 1.28 to 2.62], p = 0.001). Concurrent benzodiazepine prescription also increased mortality risk after consideration of duration of OAT (adjusted HR for DRP with benzodiazepine concurrent prescription 3.34 [95% CI 2.14 to 5.20], p < 0.001). The main limitation of this study is the possibility that unmeasured confounding factors led to an association between benzodiazepine prescription and DRP that is not causal. CONCLUSIONS: In this study, co-prescription of benzodiazepine was specifically associated with increased risk of DRP in opioid-dependent individuals. Co-prescription of z-drugs and gabapentinoids was also associated with increased mortality risk; however, for z-drugs there was no evidence for a dose-response effect on DRP, and for gabapentinoids the increased mortality risk was not specific to DRP. Concurrent prescription of benzodiazepine was associated with longer treatment but still increased risk of death overall. Clinicians should be cautious about prescribing benzodiazepines to opioid-dependent individuals.
Effects of core stability exercise for patients with neck pain: A protocol for systematic review and meta-analysis.
He Y, Sun W, Zhao X … +3 more , Ma M, Zheng Z, Xu L
Medicine (Baltimore) · 2019 Nov · PMID 31725601 · Full text
BACKGROUND: Neck pain is an important cause of disability. In spite of its high prevalence rate, treatment of the disorder is a challenging topic. Exercise therapy appears to be effective at decreasing pain and improving...
BACKGROUND: Neck pain is an important cause of disability. In spite of its high prevalence rate, treatment of the disorder is a challenging topic. Exercise therapy appears to be effective at decreasing pain and improving function for patients with NP in practice guidelines. Core stability exercise is becoming increasingly popular for NP. However, it is currently unknown whether core stability exercise produces more beneficial effects than general exercise in patients with NP. The aim of this study is to explore the therapeutic effect of core stability exercise for neck pain. METHODS: This review will only include randomized controlled trials (RCTs). Published articles from July 2009 to July 2019 will be identified using electronic searches. Search strategy will be performed in 3 English databases, 1 Chinese database, and the WHO International Clinical Trials Registry Platform. Two reviewers will screen, select studies, extract data, and assess quality independently. The methodological quality including the risk of bias of the included studies will be evaluated using a modified assessment form, which is based on Cochrane assessment tool and Physiotherapy Evidence Database scale. Review Manager Software (Revman5.3) will be used for heterogeneity assessment, generating funnel-plots, data synthesis, subgroup analysis, and sensitivity analysis. We will use GRADE system to evaluate the quality of our evidence. RESULTS: We will provide some more practical and targeted results investigating the effect of Core Stability Exercise (CSE) for Neck Pain (NP) in the current meta-analysis. Meanwhile, we will ascertain study progress of Core Stability Exercise for Neck Pain and find out defects or inadequacies of previous studies, so that future researchers could get beneficial guidance for more rigorous study. CONCLUSION: The stronger evidence about Neck Pain's rehabilitative effect and safety will be provided for clinicians and policymakers. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017055711. ETHICS AND DISSEMINATION: We do not apply for formal ethical approval from ethics committee because all of the study data in our review will be obtained in an anonymous way. Findings of this study are projected to be disseminated through peer-review publications.
Shugan Yiyang capsule for the treatment of erectile dysfunction: A protocol for systematic review and meta-analysis of randomized controlled trials.
Yan X, Li J, Yang F … +4 more , Huang X, Tan K, Dong L, Yu X
Medicine (Baltimore) · 2019 Nov · PMID 31689775 · Full text
BACKGROUND: Erectile dysfunction (ED) is a common disease. It affects the quality of life of both husband and wife and becomes an independent risk factor for cardiovascular events. In China, Shugan Yiyang (SGYY) capsule...
BACKGROUND: Erectile dysfunction (ED) is a common disease. It affects the quality of life of both husband and wife and becomes an independent risk factor for cardiovascular events. In China, Shugan Yiyang (SGYY) capsule has been increasingly reported in clinical trials for the treatment of ED and reported inconsistent findings. Therefore, it is necessary to conduct a systematic review to evaluate the efficacy and safety of this drug for the treatment of ED. METHODS: Chinese and English literature of SGYY capsule for ED published before August 31, 2019 will be comprehensive searched in PubMed, Cochrane Library, EMBASE, WANFANG, China National Knowledge Infrastructure, VIP Chinese Science and Technology Journal Database, Chinese biomedical document service system, and Clinicaltrials.gov. All randomized controlled trials that meet the eligibility criteria will be included and other studies will be excluded. Two investigators will conduct literature screening, data extraction and assess risk of bias alone, and the third investigator will handle disagreements. Two outcomes involving the international index of erectile function 5 score and adverse events will be evaluated. RevMan 5.3 and Stata 14.0 will be used to conduct this systematic review. The preferred reporting items for systematic reviews and meta-analysis protocols (PRISMA-P) statement is followed in this protocol and the the PRISMA statement will be followed in the completed systematic review. CONCLUSION AND DISSEMINATION: The efficacy and safety of SGYY capsule for ED will be evaluated. We will publish the results of this systematic review in peer-reviewed journals to provide new evidence to clinicians.Registration information: PROSPERO CRD42019140903.
Does long-term use of antidiabetic drugs changes cancer risk?
Liu YC, Nguyen PA, Humayun A … +10 more , Chien SC, Yang HC, Asdary RN, Syed-Abdul S, Hsu MH, Moldovan M, Yen Y, Li YJ, Jian WS, Iqbal U
Medicine (Baltimore) · 2019 Oct · PMID 31577776 · Full text
Antidiabetic medications are commonly used around the world, but their safety is still unclear. The aim of this study was to investigate whether long-term use of insulin and oral antidiabetic medications is associated wi...
Antidiabetic medications are commonly used around the world, but their safety is still unclear. The aim of this study was to investigate whether long-term use of insulin and oral antidiabetic medications is associated with cancer risk.We conducted a well-designed case-control study using 12 years of data from Taiwan's National Health Insurance Research Database and investigated the association between antidiabetic medication use and cancer risk over 20 years. We identified 42,500 patients diagnosed with cancer and calculated each patient's exposure to antidiabetic drugs during the study period. We matched cancer and noncancer subjects matched 1:6 by age, gender, and index date, and used Cox proportional hazard regression and conditional logistic regression, adjusted for potential confounding factors, that is, medications and comorbid diseases that could influence cancer risk during study period.Pioglitazone (adjusted odds ratio [AOR], 1.20; 95% confidence interval [CI], 1.05-1.38); and insulin and its analogs for injection, intermediate or long acting combined with fast acting (AOR, 1.22; 95% CI, 1.05-1.43) were significantly associated with a higher cancer risk. However, metformin (AOR, 1.00; 95% CI, 0.93-1.07), glibenclamide (AOR, 0.98; 95% CI, 0.92-1.05), acarbose (AOR, 1.06; 95% CI, 0.96-1.16), and others do not show evidence of association with cancer risk. Moreover, the risk for specific cancers among antidiabetic users as compared with nonantidiabetic medication users was significantly increased for pancreas cancer (by 45%), liver cancer (by 32%), and lung cancer (by 18%).Antidiabetic drugs do not seem to be associated with an increased cancer risk incidence except for pioglitazone, insulin and its analogs for injection, intermediate or long acting combined with fast acting.
Clinical application of low-dose misoprostol in the induced labor of 16 to 28 weeks pathological pregnancies (a STROBE-compliant article).
Yang Y, Wang Y, Du X … +2 more , Duan J, Huang YM
Medicine (Baltimore) · 2019 Oct · PMID 31577749 · Full text
Oral mifepristone combined with rivanol lactate (rivanol) is commonly used in second-trimester pregnancy termination. However, rivanol is not suitable to premature rupture of membranes and oligohydramnios because amnioce...
Oral mifepristone combined with rivanol lactate (rivanol) is commonly used in second-trimester pregnancy termination. However, rivanol is not suitable to premature rupture of membranes and oligohydramnios because amniocentesis is difficult. Mifepristone combined with misoprostol is suitable for the patients with oligohydramnios. In accordance with the misoprostol dosing recommendations by the International Federation of Gynecology and Obstetrics (FIGO), the incidences of uterine rupture and cervical laceration are relatively high in Chinese pregnant women. The aim of our study was to optimize misoprostol dosing regimen in terms of efficacy and safety in Chinese pregnant women.We modified the Bishop Score, and then gave patients low-dose misoprostol according to the modified Bishop score. Based on the amniotic fluid volume (AFV) indicated by type-B ultrasonic instrument, the cases with AFV ≤2 cm receiving low-dose misoprostol combined with mifepristone and the cases with amniocentesis failure followed by receiving low-dose misoprostol combined with mifepristone were enrolled into study group, and the cases with AFV >2 cm receiving rivanol combined with mifepristone were enrolled into control group. The start time of uterine contractions, time of fetal expulsion, birth process, hospital day, successful induced labor rate, complete induced labor rate, and incomplete induced labor rate were observed and compared between the 2 groups.There were significant differences in the start time of uterine contractions, time of fetal expulsion, birth process, and hospital day between the control group and the study group (all P < .05). The successful induced labor rate, complete induced labor rate, and incomplete induced labor rate were also significantly different between the 2 groups (all P < .05).In the induced labor of 16 to 28 weeks pathological pregnancy, low-dose misoprostol can markedly improve the successful induced labor rate and complete induced labor rate, shorten the birth process and hospital day, and decrease uterine curettage rate and uterine rupture risk. Low-dose misoprostol combined with mifepristone is suitable to the induced labor of 16 to 28 weeks pathological pregnancy in Chinese women.
Tai Chi for patients with mild cognitive impairment: A protocol for a systematic review and meta-analysis of randomized controlled trials.
Yang J, Chon TY, Li G … +6 more , Mallory MJ, Bublitz SE, Do A, Xiao L, Xiong D, Bauer BA
Medicine (Baltimore) · 2019 Oct · PMID 31577701 · Full text
BACKGROUND: Mild cognitive impairment (MCI) is an intermediate stage between the cognitive changes of normal aging and early dementia. Tai Chi (TC) may be particularly beneficial to patients with MCI due to its whole-bod...
BACKGROUND: Mild cognitive impairment (MCI) is an intermediate stage between the cognitive changes of normal aging and early dementia. Tai Chi (TC) may be particularly beneficial to patients with MCI due to its whole-body coordination characteristics. This systematic review protocol aims to outline the methods that will be used to assess the comparative effectiveness and safety of TC for MCI through a systematic review and meta-analysis. METHODS: A systematic review will identify and evaluate randomized controlled trials (RCTs) that examined the effects and safety of TC compared to a placebo, conventional treatment, and no treatment on cognitive function in individuals with MCI. Studies from databases of MEDLINE, PubMed, Embase, Global Health, Cochrane Library, and Scopus from January 1990 to March 2019 reported in English will be searched. Two independent reviewers will screen the studies for inclusion with the eligibility criteria and extract data. Risk of bias of individual studies will be assessed in line with Cochrane risk of bias tool. The overall quality of cumulative evidence will be assessed using selected Grading of Recommendations, Assessment, Development, and Evaluations criteria. Statistics will be used for heterogeneity assessment, sensitivity analysis, data synthesis, generating funnel plots, and subgroup analysis. Meta-analysis will be performed, if sufficiently homogeneous studies are found. A narrative synthesis will be conducted, grouping studies by exposure and outcome definitions, and describing any differences by subgroups. RESULTS: This study will provide practical and targeted evidence in investigating the impact of TC exercise for individuals with MCI. CONCLUSION: The findings of our study will provide updated evidence to determine whether TC is an effective intervention to patients with MCI. TRIAL REGISTRATION NUMBER: International Prospective Register for Systematic Reviews (PROSPERO) number CRD42019125104.
Standard median sternotomy, right minithoracotomy, totally thoracoscopic surgery, percutaneous closure, and transthoracic closure for atrial septal defects in children: A protocol for a network meta-analysis.
Yi K, Guo X, You T … +4 more , Wang Y, Ding F, Hou X, Zhou L
Medicine (Baltimore) · 2019 Sep · PMID 31568005 · Full text
BACKGROUND: Atrial septal defect (ASD) is one of the most common congenital heart diseases, with an average of 1.64 per 1000 newborns with the ASD. Empirical studies suggest that surgery should be performed early in the...
BACKGROUND: Atrial septal defect (ASD) is one of the most common congenital heart diseases, with an average of 1.64 per 1000 newborns with the ASD. Empirical studies suggest that surgery should be performed early in the presence of right atrium and or right ventricular enlargement, even for asymptomatic patients. Many surgical procedures can be used to treat ASD. But which method is the best choice remains unclear. This study aims to compare the efficacy and safety of standard median sternotomy, right minithoracotomy, totally thoracoscopic surgery, percutaneous closure, transcutaneous by echocardiography, and transcutaneous by radiotherapy for ASDs in children using Bayesian network meta-analysis (NMA). METHODS: We will perform a comprehensive literature search using PubMed, EMBASE.com, the Cochrane Library, Web of Science, and Chinese Biomedical Literature Database to identify relevant studies from inception to April 2019. Randomized controlled trials, prospective or retrospective cohort studies that reported the efficacy and safety of surgical procedures for the treatment of atrial septal defects will be included. Risk of bias of the included randomized controlled trials and prospective or retrospective cohort studies will be evaluated according to the Cochrane Handbook 5.1.0 and the risk of bias in non-randomized studies of interventions, respectively. A Bayesian NMA will be performed using R 3.4.1. RESULTS: The results of this NMA will be submitted to a peer-reviewed journal for publication. CONCLUSION: This NMA will summarize the direct and indirect evidence to assess the efficacy and safety of different surgical procedures for the treatment of ASDs. ETHICS AND DISSEMINATION: Ethics approval and patient consent are not required as this study is a network meta-analysis based on published trials. PROSPERO REGISTRATION NUMBER: CRD42019130902.
Safety and efficacy of acupuncture for the treatment of chronic obstructive pulmonary disease: A systematic review protocol.
Yu M, Gao L, Kong Y … +7 more , Yan Y, Shi Q, Si D, Bao H, Sun H, Li L, Li Y
Medicine (Baltimore) · 2019 Sep · PMID 31517846 · Full text
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease with increasing morbidity and mortality that cause huge social and economic loss. Although recommended by guidelines, pulmo...
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease with increasing morbidity and mortality that cause huge social and economic loss. Although recommended by guidelines, pulmonary rehabilitation has not been widely applied in clinics because of its inherent limitations. Acupuncture therapy (AT) as one of the most popular treatments in traditional Chinese medicine has been used to treat COPD. We aim to evaluate the safety and efficacy of acupuncture in the treatment of COPD. METHODS: Web of science, PubMed, Springer, Medline, Cochrane Library, EBASE, WHO International Clinical Trials Registry Platform (ICTRP), China National Knowledge Infrastructure Database (CNKI), Wan Fang Database, Chinese Scientific Journal Database (VIP), and Chinese Biomedical Literature Database will be searched from their inception to May 10, 2019. Randomized controlled trials that evaluated the safety and efficacy of acupuncture for the treatment on patients with COPD will be included. The primary outcome measures will include Dyspnea scores, lung function and blood eosinophils. The secondary outcome measures will include St George's Respiratory Questionnaire and 6-minute walk distance. Study selection, data extraction, and risk of bias assessment will be independently undertaken, respectively. Statistical analysis will be conducted by RevMan software (version 5.3). RESULTS: This study will provide high-quality synthesis based on current evidence of acupuncture treatment for COPD in several aspects, including symptom score, quality of life score, side effects and laboratory examination, such as lung function text, blood eosinophils (EOS) etc. CONCLUSION:: The results of this study will provide updated evidence for weather acupuncture is an effective and safe intervention for COPD. ETHICS AND DISSEMINATION: It is not necessary for this systematic review to acquire an ethical approval. This review will be disseminated in a peer-reviewed journal or conference presentation. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42019136087.
Effects and safety of herbal medicines on patients with overactive bladder: A protocol for a systematic view and meta-analysis.
Zhou J, Jiang C, Wang P … +4 more , He S, Qi Z, Shao S, Tang Y
Medicine (Baltimore) · 2019 Sep · PMID 31517818 · Full text
BACKGROUND: Overactive bladder (OAB) is a common disease in the urinary system. The morbidity is increasing annually. Herbal medicines have been pervasively used in the therapy of OAB. However, systematic review or meta-...
BACKGROUND: Overactive bladder (OAB) is a common disease in the urinary system. The morbidity is increasing annually. Herbal medicines have been pervasively used in the therapy of OAB. However, systematic review or meta-analysis has not been found to assess the effects and safety of herbal medicines in curing OAB at present. Hence, the systematic review is conducted to scientifically and methodically evaluate the value of its effectiveness and safety of herbal medicines on OAB. METHODS: We will collect all randomized controlled trials (RCTs) to assess the effectiveness and safety of herbal medicines on OAB. The RCTs will be searched from the electronic databases, including 7 English databases, consisting of PubMed, Excerpta Medica Database (EMBASE), MEDLINE, Web of Science, Cochrane Library, SpringerLink, and WHO International Clinical Trials Registry Platform (ICTRP), and 4 Chinese databases, namely Wanfang Chinese database, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), and Chinese Scientific Journal Database (VIP), others valid search strategy will be adopted. All the RCTs will be assessed from the databases establishment to July 2019. We will perform the meta-analysis of RCTs when the dissertation is appropriate. We will conduct an assessment including data synthesis, bias risk, and subgroup analysis by means of Review Manager software (RevMan) V.5.3.5 software while the setting condition is met. RESULTS: This systematic view and meta-analysis will generate a summary based on the current relevant research to calculate the effects and safety of herbal medicines in promoting the therapy of OAB. Furthermore, it will provide a high-quality synthesis for participants who use herbal medicine to cure OAB. CONCLUSION: The summary of our systematic view will verify whether herbal medicines intervention could be an effective and safety approach in curing OAB.
Effects of adductor canal block versus femoral nerve block in patients with anterior cruciate ligament reconstruction: A protocol for a systematic review and meta-analysis.
Liu X, Zhou J, Mao G … +4 more , Yu Q, Wu X, Sun H, Yang H
Medicine (Baltimore) · 2019 Sep · PMID 31490364 · Full text
OBJECTIVE: It is reported that both adductor canal block (ACB) and femoral nerve block (FNB) are commonly used methods for postoperative analgesia in anterior cruciate ligament (ACL) reconstruction. Currently, no record...
OBJECTIVE: It is reported that both adductor canal block (ACB) and femoral nerve block (FNB) are commonly used methods for postoperative analgesia in anterior cruciate ligament (ACL) reconstruction. Currently, no record has compared the efficacy of postoperative pain relief and the influence to quadriceps strength between them. This study aims to provide a protocol to compare the efficacy and safety between ACB and FNB for the postoperative analgesia of ACL reconstruction. METHODS: This study will be performed in accordance with the guideline of the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols. Online databases including PubMed, Embase, Web of Science, Cochrane Library, Wanfang database, and the Chinese National Knowledge Infrastructure database will be systematically searched from their inception up May 31, 2019. All randomized controlled trials will be included in present meta-analysis. The quality of enrolled literatures will be evaluated by using the Cochrane Collaboration Risk of bias Tool. Statistical analysis will be calculated by the Review Manager 5.3. RESULTS: This review will investigate the efficacy and safety of ACB compared with FNB in patients undergoing ACL reconstruction. The primary outcomes are visual analog scale, cumulative opioid consumption during 24 hours after surgery, numerical rating scale, and the time to first straight-leg raise. The secondary outcomes include maximal voluntary isometric contraction, stretching torque at 3, 6 months' follow-up, and adverse effects. CONCLUSION: Findings of this systematic review and meta-analysis will summarize the current evidence in postoperative analgesia for ACL reconstruction and also provide implications for clinical practice.
Chinese oral herbal paste for the treatment of stable chronic obstructive pulmonary disease: Protocol for a systematic review and meta-analysis.
Zeng Y, Li Y, Wei H … +5 more , Xiong C, Liao L, Miao TW, Mao B, Fu JJ
Medicine (Baltimore) · 2019 Jul · PMID 31305473 · Full text
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease with high morbidity and mortality placing heavy social and economic burden. As a kind of complementary therapy for the trea...
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease with high morbidity and mortality placing heavy social and economic burden. As a kind of complementary therapy for the treatment of stable COPD, Chinese oral herbal paste has been widely used and studied. The study aims to evaluate the clinical efficacy and safety of herbal paste in the treatment of stable COPD, and to provide evidence for its clinical application. METHODS: We will electronically search databases, including Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, EMBASE, PubMed, Chinese National Knowledge Infrastructure (CNKI), WANFANG Database, Chinese Scientific and Technological Periodical Database (VIP), and Chinese Biomedical Database (CBM), from respective inception to June 2019 to collect randomized controlled trials (RCTs) of Chinese oral herbal paste for the treatment of stable COPD. The websites of Chinese clinical trial registry and international clinical trial registry, the reference lists of the retrieved articles, conference proceedings, and gray literature will also be collected. The quality of life, symptom scores, and exacerbation frequency will be measured as primary outcomes. Secondary outcomes include scores of traditional Chinese medicine (TCM) syndrome, clinical effective rates according to criteria in TCM, changes in lung function, 6-minute walking distance, and safety analysis. The Cochrane bias risk assessment and the GRADE method will be used to assess the quality of the original studies included. Merging analysis of data will be performed using Rev Man 5.3 software. RESULTS: The systematic review will provide an evidence on the clinical efficacy and safety of Chinese oral herbal paste for the treatment of stable COPD, and will be submitted for publication in a peer-reviewed journal. CONCLUSION: The study will confirm whether Chinese oral herbal paste is an effective and safe intervention for the prevention and treatment of stable COPD.
Kawasaki disease and 13-valent pneumococcal conjugate vaccination among young children: A self-controlled risk interval and cohort study with null results.
Baker MA, Baer B, Kulldorff M … +7 more , Zichittella L, Reindel R, DeLuccia S, Lipowicz H, Freitas K, Jin R, Yih WK
PLoS Med · 2019 Jul · PMID 31265459 · Full text
BACKGROUND: Kawasaki disease is an acute vasculitis that primarily affects children younger than 5 years of age. Its etiology is unknown. The United States Vaccine Safety Datalink conducted postlicensure safety surveilla...
BACKGROUND: Kawasaki disease is an acute vasculitis that primarily affects children younger than 5 years of age. Its etiology is unknown. The United States Vaccine Safety Datalink conducted postlicensure safety surveillance for 13-valent pneumococcal conjugate vaccine (PCV13), comparing the risk of Kawasaki disease within 28 days of PCV13 vaccination with the historical risk after 7-valent PCV (PCV7) vaccination and using chart-validation. A relative risk (RR) of 2.38 (95% CI 0.92-6.38) was found. Concurrently, the Food and Drug Administration (FDA) conducted a postlicensure safety review that identified cases of Kawasaki disease through adverse event reporting. The FDA decided to initiate a larger study of Kawasaki disease risk following PCV13 vaccination in the claims-based Sentinel/Postlicensure Rapid Immunization Safety Monitoring (PRISM) surveillance system. The objective of this study was to determine the existence and magnitude of any increased risk of Kawasaki disease in the 28 days following PCV13 vaccination. METHODS AND FINDINGS: The study population included mostly commercially insured children from birth to <24 months of age in 2010 to 2015 from across the US. Using claims data of participating Sentinel/PRISM data-providing organizations, PCV13 vaccinations were identified by means of current procedural terminology (CPT), Healthcare Common Procedure Coding System (HCPCS), and National Drug Code (NDC) codes. Potential cases of Kawasaki disease were identified by first-in-365-days International Classification of Diseases 9th revision (ICD-9) code 446.1 or International Classification of Diseases 10th revision (ICD-10) code M30.3 in the inpatient setting. Medical records were sought for potential cases and adjudicated by board-certified pediatricians. The primary analysis used chart-confirmed cases with adjudicated symptom onset in a self-controlled risk interval (SCRI) design, which controls for time-invariant potential confounders. The prespecified risk interval was Days 1-28 after vaccination; a 28-day-long control interval followed this risk interval. A secondary analytic approach used a cohort design, with alternative potential risk intervals of Days 1-28 and Days 1-42. The varying background risk of Kawasaki disease by age was adjusted for in both designs. In the primary analysis, there were 43 confirmed cases of Kawasaki disease in the risk interval and 44 in the control interval. The age-adjusted risk estimate was 1.07 (95% CI 0.70-1.63; p = 0.76). In the secondary, cohort analyses, which included roughly 700 potential cases and more than 3 million person-years, the risk estimates of potential Kawasaki disease in the risk interval versus in unexposed person-time were 0.84 (95% CI 0.65-1.08; p = 0.18) for the Days 1-28 risk interval and 0.97 (95% CI 0.79-1.19; p = 0.80) for the Days 1-42 risk interval. The main limitation of the study was that we lacked the resources to conduct medical record review for all the potential cases of Kawasaki disease. As a result, potential cases rather than chart-confirmed cases were used in the cohort analyses. CONCLUSIONS: With more than 6 million doses of PCV13 administered, no evidence was found of an association between PCV13 vaccination and Kawasaki disease onset in the 4 weeks after vaccination nor of an elevated risk extending or concentrated somewhat beyond 4 weeks. These null results were consistent across alternative designs, age-adjustment methods, control intervals, and categories of Kawasaki disease case included.
Clinical efficacy and safety of percutaneous coronary intervention for acute myocardial infarction complicated with chronic renal insufficiency: A protocol of systematic review and meta-analysis.
Luo L, Xu WQ, Zhong RX … +4 more , Chen F, Fu YL, Zhang P, Xiao SH
Medicine (Baltimore) · 2019 Jun · PMID 31192944 · Full text
BACKGROUND: The aim of this research is to further evaluate the efficacy and safety of percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI) complicated with chronic renal insufficie...
BACKGROUND: The aim of this research is to further evaluate the efficacy and safety of percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI) complicated with chronic renal insufficiency (CRI) by meta-analysis, to provide scientific and effective medical evidence for PCI in patients with AMI complicated with CRI, and to support the clinical application of PCI. METHODS: Electronic databases will be searched, including PubMed, Cochrane Library, Embase, CNKI, CBM, VIP, and Wanfang Data. Patients with AMI complicated by renal insufficiency treated with PCI will be included. The retrieval time is from inception to January 2019. The inclusion and exclusion criteria are formulated to search only the relevant literature. Endnote software management for literature will be adopted. The literature will be independently screened by 2 researchers. Excel 2016 will be applied to extract literature data with the "Research Information Registration Form." The final selected literature will be assessed for bias risk. Stata 12.0 software will be used for the meta-analysis. RESULTS: The systematic evaluation and meta-analysis will be carried out strictly in accordance with the requirements of the Cochrane System Evaluator Manual 5.3 on meta-analyses, which will provide a high-quality evaluation of the clinical efficacy and safety of PCI in patients with AMI and CRI. ETHICS AND DISSEMINATION: This study belongs to the category of systematic reviews, not clinical trials. Therefore, it does not require ethical approval. The results of this study will be published in influential international academic journals related to this topic. CONCLUSION: PCI is an effective and safe treatment for patients with AMI and CRI. This study will provide a definite evidence-based medical conclusion and provide a scientific basis for the clinical treatment of patients with AMI and CRI. PROSPERO REGISTRATION NUMBER: CRD42019131367.
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