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1.
BMJ ; 366: l4673, 2019 08 12.
Artigo em Inglês | MEDLINE | ID: mdl-31405892

RESUMO

OBJECTIVE: To investigate whether vitamin D supplementation is associated with lower mortality in adults. DESIGN: Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES: Medline, Embase, and the Cochrane Central Register from their inception to 26 December 2018. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials comparing vitamin D supplementation with a placebo or no treatment for mortality were included. Independent data extraction was conducted and study quality assessed. A meta-analysis was carried out by using fixed effects and random effects models to calculate risk ratio of death in the group receiving vitamin D supplementation and the control group. MAIN OUTCOME MEASURES: All cause mortality. RESULTS: 52 trials with a total of 75 454 participants were identified. Vitamin D supplementation was not associated with all cause mortality (risk ratio 0.98, 95% confidence interval 0.95 to 1.02, I2=0%), cardiovascular mortality (0.98, 0.88 to 1.08, 0%), or non-cancer, non-cardiovascular mortality (1.05, 0.93 to 1.18, 0%). Vitamin D supplementation statistically significantly reduced the risk of cancer death (0.84, 0.74 to 0.95, 0%). In subgroup analyses, all cause mortality was significantly lower in trials with vitamin D3 supplementation than in trials with vitamin D2 supplementation (P for interaction=0.04); neither vitamin D3 nor vitamin D2 was associated with a statistically significant reduction in all cause mortality. CONCLUSIONS: Vitamin D supplementation alone was not associated with all cause mortality in adults compared with placebo or no treatment. Vitamin D supplementation reduced the risk of cancer death by 16%. Additional large clinical studies are needed to determine whether vitamin D3 supplementation is associated with lower all cause mortality. STUDY REGISTRATION: PROSPERO registration number CRD42018117823.


Assuntos
Suplementos Nutricionais , Mortalidade , Vitamina D/administração & dosagem , Colecalciferol/administração & dosagem , Ergocalciferóis/administração & dosagem , Humanos , Neoplasias/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto
2.
Lancet ; 394(10196): 420-431, 2019 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-31379333

RESUMO

Developments in high-throughput microbial genomic sequencing and other systems biology techniques have given novel insight into the potential contribution of the gut microbiota to health and disease. As a result, an increasing number of diseases have been characterised by distinctive changes in the composition and functionality of the gut microbiota; however, whether such changes are cause, consequence, or incidental to the disease in question remains largely uncertain. Restoration of the gut microbiota to a premorbid state is a key novel therapeutic approach of interest, and faecal microbiota transplantation-the transfer of prescreened stool from healthy donors into the gastrointestinal tract of patients-is gaining increasing importance in both the clinical and research settings. At present, faecal microbiota transplantation is only recommended in the treatment of recurrent Clostridioides difficile infection, although a large number of trials are ongoing worldwide exploring other potential therapeutic indications.


Assuntos
Infecções por Clostridium/terapia , Transplante de Microbiota Fecal/tendências , Microbioma Gastrointestinal , Humanos , Guias de Prática Clínica como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
3.
Medicine (Baltimore) ; 98(33): e16607, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415353

RESUMO

BACKGROUND: We performed this meta-analysis to assess the efficacy and safety of Jianpi Liqi therapy (JLT), a traditional Chinese medicine therapy, in treating functional dyspepsia (FD). METHODS: We systematically searched 13 databases from their inception to 15th, May 2019. Eligible studies were randomized controlled trials (RCTs) that compared JLT medicine with conventional pharmacotherapy (CP) in treating patients with FD. Cochrane Collaboration tool, Review Manager 5.3 and STATA 11.0, GRADE profiler 3.6 were used for evaluating risk of bias, analyzing, and assessing quality of evidence respectively. RESULTS: After exclusions, 15 RCTs including a total of 1451 participants were included for analysis. We found evidence that JLT had better efficacy than CP (domperidone, omeprazole, esomeprazole, mosapride, lansoprazole, compound digestive enzymes, lactasin tablets) for FD (OR 0.34; 95% CI 0.26, 0.45; P < .00001). Moreover, JLT had more improvement on symptoms including abdominal pain, abdominal distention, early satiety, belching, poor appetite, and fatigue compared with CP. In addition, serious adverse events were not observed in treatment courses. CONCLUSION: This meta-analysis suggested that JLT appears to have better efficacy in treating FD compared with CP. It may be an effective and safe therapy option for patients with FD. Though, more large-sample and strictly designed RCTs are needed to confirm our findings.PROSPERO registration number: CRD42019133241.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Dispepsia/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
4.
Medicine (Baltimore) ; 98(33): e16637, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415357

RESUMO

BACKGROUND: The goal of the current meta-analysis and systematic review was to explore the efficacy of tiotropium in treating patients with moderate-to-severe asthma on the basis of qualified randomized controlled trials (RCTs). METHODS: The following online electronic databases, such as Cochrane, PubMed, and Embase database were screened to identify qualified studies updated to January 2019 through the use of index words. Several literatures that were relevant to the present analysis were also included. To further analyze the main outcomes, we utilized the odds rations (OR), and mean difference (MD) along with its 95% confidence interval (95% CI). RESULTS: A total of 14 RCTs with 4998 patients in the tiotropium group and 5074 patients in the control group were included in the present study. On the basis of the pooled results, tiotropium was significantly associated with improved morning PEF (SMD: 3.29, 95%CI: 2.03-4.55), evening PEF (SMD: 3.36, 95%CI: 2.24-4.48), peak FEV (SMD: 2.67, 95%CI: 1.47-3.88), and trough FEV (SMD: 1.90, 95%CI: 0.87-2.92) vs the control group. Nevertheless, no significant difference was observed in peak FVC (SMD: 0.77, 95%CI: -0.21-1.76), trough FVC (SMD: 0.67, 95%CI: -0.18-1.53), AE (RR: 0.98, 95%CI: 0.94-1.02) and serious AE (RR: 1.08, 95%CI: 0.77-1.52) between the 2 groups. CONCLUSIONS: In this review, we summarized the significant effect of tiotropium for the treatment of moderate-to-severe asthma, mainly in increasing morning PEF, evening PEF, peak FEV and trough FEV based on high-quality RCTs. Nevertheless, no significant difference in peak FVC, trough FVC, AE and serious AE was found between the 2 groups. A close comparison of the 2 groups revealed that more high-quality larger-sample RCTs are needed to gather more strong evidence on the therapeutic efficacy and safety of tiotropium for clinical practice.


Assuntos
Asma/tratamento farmacológico , Broncodilatadores/uso terapêutico , Brometo de Tiotrópio/uso terapêutico , Adulto , Asma/patologia , Criança , Feminino , Volume Expiratório Forçado/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Pico do Fluxo Expiratório/efeitos dos fármacos , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Capacidade Vital/efeitos dos fármacos
5.
Medicine (Baltimore) ; 98(33): e16803, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415391

RESUMO

BACKGROUND: This proposed study will systematically assess the effect and safety of cognitive-behavioral therapy (CBT) for heart failure (HF). METHODS: We will search the following electronic databases for randomized controlled trials assessing the effect of CBT in patients with HF: PUBMED, EMBASE, Cochrane Library, Web of Science, Scopus, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, VIP Information, and Wanfang Data from their inceptions to present without any language limitations. Two authors will independently conduct the study selection, data extraction, and methodological quality assessment. The methodological quality will be evaluated by Cochrane risk of bias tool. RESULTS: This study will assess the efficacy and safety of CBT for patients with HF. The primary outcomes consist of depression and anxiety. The secondary outcomes comprise of all-cause mortality, change in body weight, urine output, change in serum sodium; and any adverse events. CONCLUSION: The results of this study will summarize the up-to-date evidence on the effect and safety of CBT for HF. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42019135932.


Assuntos
Ansiedade/terapia , Terapia Cognitivo-Comportamental/métodos , Depressão/terapia , Insuficiência Cardíaca/psicologia , Adulto , Idoso , Ansiedade/etiologia , Depressão/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Revisão Sistemática como Assunto , Resultado do Tratamento
6.
Medicine (Baltimore) ; 98(33): e16850, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415414

RESUMO

BACKGROUND: Type 1 Diabetes Mellitus (T1DM) has long required insulin treatment. Sotagliflflozin (SOTA), as a dual SGLT-1/2 inhibitor, has the potential to be the first oral antidiabetic drug (OAD) to be approved for T1DM in the US market. It is important to evaluate the effectiveness of SOTA for T1DM. METHODS: Web of Science, PubMed datebase, Cochrane Library, Embase, Clinical Trials, and CNKI will be searched to identify randomized controlled trials (RCTs) exploring SOTA adjuvant therapy for T1DM. Strict screening and quality evaluation will be performed on the obtained literature independently by 2 researchers; outcome indexes will be extracted. The bias risk of the included studies will be evaluated based on Cochrane assessment tool. Meta-analysis will be performed on the data using Revman 5.3 software. RESULT: We will provide practical and targeted results assessing the efficacy and safety of SOTA for T1DM patients, to provide reference for clinical use of SOTA. CONCLUSION: The stronger evidence about the efficacy and safety of SOTA for T1DM patients will be provided for clinicians. TRIAL REGISTRATION NUMBER: PROSPERO CRD42019133099.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Glicosídeos/administração & dosagem , Inibidores do Transportador 2 de Sódio-Glicose/administração & dosagem , Administração Oral , Terapia Combinada , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisão Sistemática como Assunto
7.
Medicine (Baltimore) ; 98(33): e16855, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415417

RESUMO

BACKGROUND: Endometrial cancer (EC) is one of the most common gynecologic tumors, with a high incidence in developed countries. Although the overall prognosis is good, some women have invasive tumors, the risk of recurrence, and death is high. The common surgical methods used in EC are total-abdominal hysterectomy (TAH), total-vaginal hysterectomy (TVH), laparoscopic-assisted vaginal hysterectomy (LAVH), and total-laparoscopic hysterectomy (TLH) including both conventional and robotically assisted. METHODS: The literature search was performed in The Cochrane Central Register of Controlled Trials, PubMed, Web of Science, and Embase. The randomized controlled trials (RCTs) will be included. The search date is until June 2019. The risk of bias of included RCTs was assessed by 2 investigators according to the Cochrane Collaboration's tool. Network meta-analysis will be conducted by R software. RESULTS: This study is ongoing and the results will be submitted to a peer-reviewed journal for publication. CONCLUSION: This network meta-analysis will provide clinical staff with current and reliable information on the best surgical approach for EC. Ethical approval is not applicable, since this is a network mate-analysis based on published articles. The protocol has been registered on PROSPERO under the number CRD42019128094.


Assuntos
Neoplasias do Endométrio/cirurgia , Histerectomia Vaginal/métodos , Recidiva Local de Neoplasia/cirurgia , Neoplasias do Endométrio/mortalidade , Feminino , Humanos , Laparoscopia/métodos , Recidiva Local de Neoplasia/mortalidade , Meta-Análise em Rede , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos Cirúrgicos Robóticos/métodos
8.
Medicine (Baltimore) ; 98(33): e16856, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415418

RESUMO

BACKGROUND: Clinical trials have reported that flap repair (FR) can treat anal fistula (AF) effectively. However, no study systematically investigated its efficacy and safety for patients with AF. This study will systematically assess its efficacy and safety of AF. METHODS: We will retrieve MEDLINE, EMBASE, Cochrane Library, Elsevier, Springer, Web of Science, Scopus, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, VIP Information, and Wanfang Data from their inceptions to May 1, 2019 without any language limitations. The primary outcome is fistula cure rate. The secondary outcomes consist of fistula recurrence rate, fecal continence, quality of life, and complications. RevMan 5.3 software will be used for methodological quality assessment, data synthesis, subgroup analysis and sensitivity analysis. RESULTS: The results of this study will summarize a high-quality synthesis of current evidence for the treatment of FR for patients with AF. CONCLUSION: The findings of this proposed study will provide evidence for judging whether FR is an effective and safety intervention for AF or not.PROSPERO registration number: PROSPERO CRD42019135507.


Assuntos
Fístula Retal/cirurgia , Retalhos Cirúrgicos , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Retalhos Cirúrgicos/efeitos adversos , Revisão Sistemática como Assunto , Resultado do Tratamento
9.
Medicine (Baltimore) ; 98(33): e16857, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415419

RESUMO

BACKGROUND: Postoperative nausea and vomiting (PONV) are common complications following surgery and anesthesia, conventional drugs can carry some side effect in treating PONV. Acupressure PC6 point has been widely used in clinical, but there still exist controversy towards its effectiveness and safety. We, therefore, design this study to systematically assess the effectiveness and safety of acupressure PC6 point for treating PONV. METHODS AND ANALYSIS: Nine online databases will be searched from their inception to May 2019. We will include randomized controlled trials (RCTs) involving patients with PONV and receiving acupressure PC6 point treatment. Two independent reviewers will be responsible for the selection of studies, data extraction and risk of bias assessment. RevMan V.5.3 software will be used for data synthesis with either a fixed effects model or random effects model depending on the heterogeneity test. Evidence quality will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation system (GRADE). The primary outcome is incidence of postoperative nausea (PON), postoperative vomiting (POV) and PONV events during 0 to 6 hours and after 6 hours of the treatment. The secondary outcome is the number of people who use emergency drugs and the number of people with adverse reactions. A meta-analysis will be conducted if no considerable heterogeneity is detected. The results will be presented as risk ratios with 95% confidence interval (CIs) for dichotomous data and weighted mean differences or standardized mean differences with 95% CIs for continuous data. RESULTS: This study will provide a high-quality evidence to assess the effectiveness and safety of acupressure PC6 point for patient with PONV. CONCLUSION: This review will provide up-date evidence of whether acupressure of PC6 point is an effective and safe intervention for PONV. PROSPERO registration number: CRD42019135598.


Assuntos
Acupressão/métodos , Náusea e Vômito Pós-Operatórios/terapia , Pontos de Acupuntura , Antieméticos/efeitos adversos , Antebraço , Humanos , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisão Sistemática como Assunto
10.
Medicine (Baltimore) ; 98(33): e16870, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415424

RESUMO

BACKGROUND: Although several trials have reported the use of extracorporeal shock wave therapy (ESWT) for mild to moderate carpal tunnel syndrome (CTS), little is known about the efficacy of ESWT. Thus, we performed a meta-analysis to evaluate whether ESWT can improve symptoms, functional outcomes, and electrophysiologic parameters in CTS. METHODS: Six randomized controlled trials investigating the effect of ESWT on CTS were retrieved from PubMed, Embase, and the Cochrane Library. We performed a pairwise meta-analysis using fixed- or random-effects models. RESULTS: ESWT showed significant overall effect size compared to the control (overall Hedge g pooled standardized mean difference (SMD) = 1.447; 95% confidence interval [CI], 0.439-2.456; P = .005). Symptoms, functional outcomes, and electrophysiologic parameters all improved with ESWT treatment. However, there was no obvious difference between the efficacy of ESWT and local corticosteroid injection (pooled SMD = 0.418; 95% CI, -0.131 to 0.968; P = .135). A publication bias was not evident in this study. CONCLUSION: Our meta-analysis revealed that ESWT can improve symptoms, functional outcomes, and electrophysiologic parameters in patients with CTS. Further research is needed to confirm the long-term effects and the optimal ESWT protocol for CTS.


Assuntos
Síndrome do Túnel Carpal/terapia , Tratamento por Ondas de Choque Extracorpóreas/métodos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
11.
Medicine (Baltimore) ; 98(33): e16878, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415429

RESUMO

BACKGROUND: Guizhi Fuling pill, a famous traditional Chinese herbal formula, has been widely used for treatment of gynecological diseases. This meta-analysis sought to evaluate the add-on effect of Guizhi Fuling capsule (GZFL) to mifepristone in women with endometriosis. METHODS: A comprehensively literature search was conducted using Pubed, Embase, Cochrane Library, Wanfang, CNKI, VIP databases from their inceptions to January 25, 2019. Randomized controlled trials that compared GZFL plus mifepristone to mifepristone alone for treatment of endometriosis were eligible. Main outcomes were pregnancy, reduction of the recurrence, and serum level of follicle-stimulating hormone, luteinizing hormone, estradiol or progesterone. RESULTS: A total of 1052 women with endometriosis from 10 trials were identified and analyzed. Meta-analyses showed that GZFL plus mifepristone was superior to mifepristone in reducing the recurrence of endometriosis (RR 0.40; 95% CI 0.27-0.59) and improving the pregnancy (risk ratio [RR] 1.74; 95% confidence intervals [CI] 1.40-2.17). Moreover, adjuvant treatment with GZFL also significantly reduced serum level of estradiol (mean difference [MD] -20.83 pmol/L; 95% CI -34.01 to -7.65) and progesterone (MD -0.18 mmol/L; 95% CI -0.23 to -0.12). However, there were no significant differences in serum level of follicle-stimulating hormone (MD -0.42 U/L; 95% CI -1.16 to 0.31) and luteinizing hormone (MD -0.04 U/L; 95% CI -0.43 to 0.34). CONCLUSION: GZFL as adjuvant therapy to mifepristone appears to have additional benefits in preventing recurrence of endometriosis and improving pregnancy among women with endometriosis. However, these conclusions should be interpreted with caution due to the methodological flaws of the included trials.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Endometriose/tratamento farmacológico , Mifepristona/uso terapêutico , Quimioterapia Combinada , Feminino , Humanos , Gravidez , Taxa de Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
12.
Medicine (Baltimore) ; 98(33): e16881, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415431

RESUMO

BACKGROUND: Ulcerative colitis (UC) is a universal chronic nonspecific intestinal inflammatory disease of unknown etiology. Although 5-aminosalicylic acid (5-ASA) is used as a first-line treatment for mild-to-moderate UC, some patients do not react well to it. Traditional Chinese medicine (TCM) plays a complementary role in the management of UC. A large number of randomized controlled trials (RCTs) have shown that TCM has a significant effect in the treatment of mild-to-moderate UC. However, due to the diversity of TCM treatments, its relative effectiveness and safety remains unclear. Therefore, we aim to compare the effectiveness and safety of TCM for mild-to-moderate UC by implementing a Bayesian network meta-analysis (NMA) and provide a reference for clinical treatment. METHODS: According to the Cochrane Handbook, PubMed, MEDLINE, Embase, Web of Science, the Cochrane Library, CINAHL, China National Knowledge Infrastructure (CHKD-CNKI), Chinese Biomedical Literature database (CBM), and WANFANG database will be searched. Related randomized controlled trials (RCTs) that compared one TCM intervention with another or with 5-ASA (placebo) for mild-to-moderate UC from inceptions to February 2019 will be included. Two authors will screen the literature and extract data independently based on predesigned rules, and evaluate the risk of bias of included studies using the Cochrane Risk of Bias Tool. Both classical pair-wise meta-analysis and Bayesian NMA will be conducted using R-3.4.4 and WinBUGS-1.4.3 software. The ranking probabilities for all interventions will be estimated and the hierarchy of each intervention will be summarized as surface under the cumulative ranking curve. The consistency within network will be evaluated with Cochrane Q statistic and net-heat plot. The quality of evidence will be assessed by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. RESULTS: The study results will be disseminated through a peer-reviewed journal publication or conference presentation. CONCLUSIONS: The findings will provide a systematic evidence-based medical evidence of TCM interventions in the treatment of UC and help clinical practitioners, UC patients, and policy-makers make more informed choices in the decision-making. ETHICS AND DISSEMINATION: Ethical approval and informed consent are not required since this is a protocol for a network meta-analysis based on published studies. The findings will be disseminated through a peer-reviewed journal publication or conference presentation. REGISTRATION: PROSPERO CRD42019133962.


Assuntos
Colite Ulcerativa/terapia , Medicina Tradicional Chinesa/métodos , Terapia por Acupuntura , Teorema de Bayes , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Meta-Análise em Rede , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Resultado do Tratamento
13.
Medicine (Baltimore) ; 98(33): e16915, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415440

RESUMO

BACKGROUND: Chronic lymphocytic leukemia (CLL) is a rare hematological malignancy classified in the non-Hodgkin's lymphoma category. Ibrutinib, a first-in-class Bruton tyrosine kinase inhibitor has been approved for use in the treatment of CLL. This drug has shown beneficial effects including a higher overall response rate, sustained remissions, and a tolerable toxicity level. In this meta-analysis, we aimed to compare the adverse drug events which were associated with the use of ibrutinib for the treatment of patients with CLL. METHODS: A careful search was carried out through the Cochrane Central, EMBASE, MEDLINE (PubMed), and through www.ClinicalTrials.com. The following criteria for inclusion were considered: Both randomized trials and observational cohorts; Studies comparing the adverse drug events observed with the use of ibrutinib versus a control group for the treatment of CLL. The RevMan software (version 5.3) was used to carry out this analysis and the analyzed data were represented by risk ratios (RR) and 95% confidence intervals (CI). RESULTS: A total number of 2456 participants with CLL were included in this analysis. One thousand one hundred thirteen participants were treated with ibrutinib whereas the remaining 1343 participants were assigned to the control (non-ibrutinib) group. Results of this current analysis showed Ibrutinib not to be associated with significantly higher risk of anemia (RR: 0.90, 95% CI: 0.67-1.21; P = .49), thrombocytopenia (RR: 0.61, 95% CI: 0.32-1.14; P = .12), neutropenia (RR: 0.50, 95% CI: 0.25-1.00; P = .05), and febrile neutropenia (RR: 0.89, 95% CI: 0.32-2.49; P = .83) in these patients with CLL. The risk for respiratory tract infection was also similarly manifested (RR: 1.01, 95% CI: 0.78-1.30; P = .96). However, ibrutinib was associated with a high risk of abdominal manifestations in comparison to the control group (RR: 1.62, 95% CI: 1.32-2.00; P = .00001). The risk for diarrhea was also significantly higher in the Ibrutinib group (RR: 2.14, 95% CI: 1.44-3.17; P = .0002). CONCLUSIONS: During the treatment of CLL, ibrutinib was not associated with significantly higher risks of anemia, thrombocytopenia, or neutropenia compared to the control group. However, abdominal manifestations were significantly higher with ibrutinib. Advanced phase trials should further confirm this hypothesis.


Assuntos
Leucemia Linfocítica Crônica de Células B/tratamento farmacológico , Pirazóis/efeitos adversos , Pirimidinas/efeitos adversos , Dor Abdominal/induzido quimicamente , Constipação Intestinal/induzido quimicamente , Diarreia/induzido quimicamente , Feminino , Humanos , Masculino , Pirazóis/administração & dosagem , Pirimidinas/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto , Vômito/induzido quimicamente
14.
BMJ ; 366: l4697, 2019 08 21.
Artigo em Inglês | MEDLINE | ID: mdl-31434641

RESUMO

OBJECTIVE: To assess effects of increasing omega-3, omega-6, and total polyunsaturated fatty acids (PUFA) on diabetes diagnosis and glucose metabolism. DESIGN: Systematic review and meta-analyses. DATA SOURCES: Medline, Embase, Cochrane CENTRAL, WHO International Clinical Trials Registry Platform, Clinicaltrials.gov, and trials in relevant systematic reviews. ELIGIBILITY CRITERIA: Randomised controlled trials of at least 24 weeks' duration assessing effects of increasing α-linolenic acid, long chain omega-3, omega-6, or total PUFA, which collected data on diabetes diagnoses, fasting glucose or insulin, glycated haemoglobin (HbA1c), and/or homoeostatic model assessment for insulin resistance (HOMA-IR). DATA SYNTHESIS: Statistical analysis included random effects meta-analyses using relative risk and mean difference, and sensitivity analyses. Funnel plots were examined and subgrouping assessed effects of intervention type, replacement, baseline risk of diabetes and use of antidiabetes drugs, trial duration, and dose. Risk of bias was assessed with the Cochrane tool and quality of evidence with GRADE. RESULTS: 83 randomised controlled trials (mainly assessing effects of supplementary long chain omega-3) were included; 10 were at low summary risk of bias. Long chain omega-3 had little or no effect on likelihood of diagnosis of diabetes (relative risk 1.00, 95% confidence interval 0.85 to 1.17; 58 643 participants, 3.7% developed diabetes) or measures of glucose metabolism (HbA1c mean difference -0.02%, 95% confidence interval -0.07% to 0.04%; plasma glucose 0.04, 0.02 to 0.07, mmol/L; fasting insulin 1.02, -4.34 to 6.37, pmol/L; HOMA-IR 0.06, -0.21 to 0.33). A suggestion of negative outcomes was observed when dose of supplemental long chain omega-3 was above 4.4 g/d. Effects of α-linolenic acid, omega-6, and total PUFA on diagnosis of diabetes were unclear (as the evidence was of very low quality), but little or no effect on measures of glucose metabolism was seen, except that increasing α-linolenic acid may increase fasting insulin (by about 7%). No evidence was found that the omega-3/omega-6 ratio is important for diabetes or glucose metabolism. CONCLUSIONS: This is the most extensive systematic review of trials to date to assess effects of polyunsaturated fats on newly diagnosed diabetes and glucose metabolism, including previously unpublished data following contact with authors. Evidence suggests that increasing omega-3, omega-6, or total PUFA has little or no effect on prevention and treatment of type 2 diabetes mellitus. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017064110.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/prevenção & controle , Gorduras Insaturadas na Dieta/uso terapêutico , Prevenção Primária/métodos , Prevenção Secundária/métodos , Adulto , Glicemia/análise , Diabetes Mellitus Tipo 2/sangue , Suplementos Nutricionais , Jejum/sangue , Ácidos Graxos Ômega-3/uso terapêutico , Ácidos Graxos Ômega-6/uso terapêutico , Ácidos Graxos Insaturados/uso terapêutico , Feminino , Hemoglobina A Glicada/análise , Humanos , Insulina/sangue , Resistência à Insulina , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto
15.
Medicine (Baltimore) ; 98(34): e16882, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31441863

RESUMO

BACKGROUND: Cancer-related fatigue (CRF) is the most common and distressing symptom associated with cancer treatment that breast cancer survivors (BCS) experience. We previously found that laser moxibustion may be efficacious for CRF. The primary aim of this study is to determine the specific efficacy of 10.6 µm infrared laser moxibustion on CRF. The secondary aim is to evaluate the effect of infrared laser moxibustion on co-existing symptoms that BCS experience. METHODS: We will conduct a randomized, sham-controlled, three-arm trial of infrared laser moxibustion (ILM) against sham ILM (SILM) and waitlist control (WLC) among BCS with moderate to severe fatigue. The two intervention groups will receive either real or sham infrared laser moxibustion on four acupoints (i.e., ST36 [bilateral], CV4, and CV6) for 20 minutes each session for 6 weeks (twice per week). The primary endpoint is the change in fatigue score from Baseline to Week 6 as measured by the Chinese version of the Brief Fatigue Inventory (BFI-C). Our secondary aim is to compare the severity of co-morbidities (e.g., depression, insomnia, and pain) among the 3 groups. DISCUSSION: The results of our trial will establish evidence for the efficacy of infrared laser moxibustion for CRF, a very common and challenging symptom. TRIAL REGISTRATION NUMBER: NCT03553355.


Assuntos
Neoplasias da Mama/complicações , Sobreviventes de Câncer/psicologia , Fadiga/terapia , Raios Infravermelhos/uso terapêutico , Moxibustão/métodos , China , Feminino , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
Medicine (Baltimore) ; 98(34): e16942, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31441887

RESUMO

BACKGROUND: The optimal intensity modulated radiation therapy (IMRT) technique for head and neck cancer (HNC) has not been determined yet. The present study aimed to compare the clinical outcomes of the simultaneous integrated boost (SIB)-IMRT versus the sequential boost (SEQ)-IMRT in HNC. METHODS: A meta-analysis of 7 studies involving a total of 1049 patients was carried out to compare the treatment outcomes together with severe acute adverse effects of the SIB-IMRT versus the SEQ-IMRT in HNC patients. RESULTS: Comparison of the SIB-IMRT and SEQ-IMRT showed no significant difference in the measurement of overall survival (OS) (hazard ratio [HR] 0.94; 95% confidence inerval [CI], 0.70-1.27; P = .71), progression free survival (PFS) (HR 1.03; 95% CI, 0.82-1.30; P = .79), locoregional recurrence free survival (LRFS) (HR 0.98; 95% CI, 0.65-1.47; P = .91), and distance metastasis free survival (DMFS) (HR 0.87; 95% CI, 0.50-1.53; P = .63). Moreover, there were no significant differences in adverse effect occurrence between the SIB-IMRT and SEQ-IMRT groups. CONCLUSION: SIB-IMRT and SEQ-IMRT can provide comparable outcomes in the treatment of patients afflicted by HNC. Both IMRT techniques were found to carry a similar risk of severe acute adverse effect. SIB-IMRT may have advantages due to its convenience and short-course of treatment; however, the optimum fractionation and prescribed dose remained unclear. Furthermore, both IMRT techniques can be advocated as the technique of choice for HNC. Treatment plan should be individualized for patients.


Assuntos
Neoplasias de Cabeça e Pescoço/radioterapia , Hipofracionamento da Dose de Radiação , Radioterapia de Intensidade Modulada/métodos , Feminino , Humanos , Masculino , Radioterapia de Intensidade Modulada/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos , Resultado do Tratamento
17.
Medicine (Baltimore) ; 98(34): e16949, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31441891

RESUMO

BACKGROUND: Acute diarrhea is the 2nd highest prevalence disease among children under 5 years of age. It can cause malnutrition and even death in children, especially in developing country. Traditional Chinese medicine therapy has been applied and already in the guidelines for clinical practice of acute infectious diarrhea in children in China, but there is no specific methods or recommendations due to lacking of evidence. Zusanli acupoint injection as a form of acupuncture therapy, which is proved to be effective in randomised controlled trials (RCTs) and very suitable for children, has been used in acute diarrhea in children for a long time; therefore, a systematic review is necessary to provide available evidence for further study. METHODS: Different studies from various databases will be involved in this study. Only RCTs of children under 5 years of age diagnosed with acute diarrhea using any recognized diagnostic criteria will be included. We will search manually the literature in the databases from China Conference Paper Database. Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Internet, WanFang, Chongqing VIP, and China Biomedical Literature CDROM Database. Primary outcomes: clinical cure rate (clinical cure is defined as the frequency, timing and character of stool back to normal status, as well as disappearance of diarrhea symptoms), diarrhea duration (from admission to the cessation of diarrhea). SECONDARY OUTCOMES: stool frequency within 24 hours, rate of adverse effect. Data will be extracted by 2 researchers independently; risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: This study will synthesize and provide evidence based on the data of the currently published zusanli (ST36) acupoint injection for acute diarrhea in children under 5 years old, especially in terms of clinical efficacy and safety. CONCLUSION: This systematic review aims to evaluate the benefits and harms of zusanli acupoint injection for acute diarrhea in children under 5 years old reported in RCTs, and provide evidence reference in TCM field for Chinese guidelines on the treatment of acute diarrhea in children. ETHICS AND DISSEMINATION: This study is a systematic review; the outcomes are based on the published evidence, and hence examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations. PROSPERO REGISTRATION NUMBER: PROSPERO 2019 CRD42019135275.


Assuntos
Pontos de Acupuntura , Terapia por Acupuntura/métodos , Diarreia/terapia , Terapia por Acupuntura/efeitos adversos , Doença Aguda/terapia , Pré-Escolar , Humanos , Medicina Tradicional Chinesa/métodos , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisão Sistemática como Assunto
18.
Medicine (Baltimore) ; 98(34): e16956, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31441895

RESUMO

BACKGROUND: Knee osteoarthritis (KOA) is a common disease in elderly individuals. Many medications for KOA have the potential to cause side effects. We used Juglandis semen complex extract (JCE) consisting of 4 herbs derived from Cheong-A-Won, which has been commonly used for KOA treatment. In this study, we will evaluate whether JCE improves symptoms in patients with KOA and will identify the changes in the inflammation factor. METHODS: This study will be a single-center, randomized, double-blind, and placebo-controlled trial. Three groups, JCE 1000 mg, 2000 mg, and placebo, will be randomly allocated. Total duration of the clinical trial will be 12 to 14 weeks. Study participants will be followed up every 6 weeks and the effect and safety will be assessed at the 2, 3, and 4 visit. All participants were asked to maintain a dosage schedule for this protocol. The primary outcomes will be measured using Korean Western Ontario and McMaster Universities Questionnaire and the secondary outcomes will include pain Visual analog scale score, EuroQol Five Dimensions questionnaire, Patient Global Impression of Change, and the changes in the laboratory test parameters of inflammation. Repeated-measure analysis will be used to measure primary efficacy based on full analysis set. DISCUSSION: This study has limited inclusion and exclusion criteria and a well-controlled intervention, and it will be the first randomized controlled trial to assess the efficacy and safety of JCE in patients with KOA. This study provides insights into the mechanisms that explain the therapeutic effects of JCE in KOA and will lay the groundwork for further studies.


Assuntos
Osteoartrite do Joelho/tratamento farmacológico , Extratos Vegetais/administração & dosagem , Método Duplo-Cego , Humanos , Medicina Tradicional Coreana/métodos , Projetos Piloto , Ensaios Clínicos Controlados Aleatórios como Assunto , República da Coreia
19.
Medicine (Baltimore) ; 98(34): e16957, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31441896

RESUMO

BACKGROUND: Atopic dermatitis (AD), also called eczema, is one of the most familiar chronic diseases in childhood. A possible pathological mechanism is immune dysfunction resulting in IgE sensitization to allergens. The recent studies demonstrated that the immune system can be affected by probiotics or prebiotics. However, the effectiveness and safety of probiotics or prebiotics on prevention of eczema are still unclear. To investigate this question, we conduct a systematic review and meta-analysis. METHODS: The protocol followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. Four main databases (PubMed, Embase, the Cochrane Library, and the web of science) will be searched dating until 15 July 2019 for randomized controlled trials investigating the effects and safety of probiotics or prebiotics on prevention of eczema in children with no language restrictions. In addition, a manual search of the references of relevant published studies will also be considered.Studies selection, data extraction, and risk of bias assessment will be conducted by two independent reviewers. The primary outcome is the incidence of eczema. The second outcome is adverse events. The duration of intervention, the timing of intervention and intervention organism will be taken into consideration. RESULTS: The results will provide useful information about the effect and safety of probiotics or prebiotics on reducing the incidence of eczema in children. CONCLUSION: The findings of this study will be published in a peer-reviewed journal.PROSPERO registration number: CRD42019136528.


Assuntos
Dermatite Atópica/prevenção & controle , Eczema/prevenção & controle , Probióticos/administração & dosagem , Adulto , Criança , Feminino , Humanos , Masculino , Metanálise como Assunto , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisão Sistemática como Assunto
20.
Medicine (Baltimore) ; 98(34): e16958, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31441897

RESUMO

BACKGROUND: Asthma is a complex disease associated with many factors such as immunologic, environmental, genetic, and other factors. Common medicines used to treat asthma include ß-agonist and glucocorticoid. However, in the long-term treatment, the effect of the above-mentioned drugs is not satisfactory, so many patients choose oral Chinese medicines instead of western medicines. The introduction of Chinese medicines therapies, a rapid proliferation of the literature on management of asthma in general, call for novel ways of evidence synthesis in this area. This systematic review is to systematically summarize and evaluate a large number of evidences for Chinese herbal interventions for asthma. Evaluate the efficacy and safety of Chinese medicines in the treatment of asthma and inform a decision aid for the clinical encounter between patients and clinicians. In addition, it helps to establish a future research agenda. METHODS: Five English databases (PubMed, Web of science, EBASE, Springer Cochrane Library, and WHO International Clinical Trials Registry Platform) and 4 Chinese databases (Wanfang Database, Chinese Scientific Journal Database, China National Knowledge Infrastructure Database, and Chinese Biomedical Literature Database) will be searched normatively according to the rule of each database from the inception to the present. The literature screening, data extraction, and quality assessment will be conducted by 2 researchers independently. Data will be synthesized by either the fixed-effects or random-effects model according to a heterogeneity test. Asthma control test symptom score will be assessed as the primary outcome. The curative effect of single symptom and sign; Withdrawal and reduction of western medicines in a course of treatment, including: time, type, and quantity; Maintenance of western medicines after the course of treatment, including: type, quantity; Asthma Quality of Life Questionnaire; laboratory efficacy indexes as the secondary outcome. General physical examination; routine examination of blood, urine, and stool; electrocardiogram; liver and kidney function examination; possible adverse reactions and related detection indicators as the security indexes. Meta-analysis will be performed using RevMan5.3.5 software provided by the Cochrane Collaboration. RESULTS: This study will provide high-quality synthesis based on current evidence of Chinese medicines treatment for asthma in several aspects, including asthma control score, side effects and laboratory examination such as lung-function test, serum total immunoglobulin, and so on. CONCLUSION: The results of this study will provide updated evidence for whether Chinese medicines is an effective and safe intervention for asthma. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42019136074.


Assuntos
Asma/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Medicina Tradicional Chinesa , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisão Sistemática como Assunto , Resultado do Tratamento
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