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1.
Psychiatr Danub ; 32(Suppl 1): 53-57, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32890363

RESUMO

BACKGROUND: Seafarers are usually exposed to many stressors that are related to different duties on board. Several notable researchers have argued that stress is a transactional phenomenon between the individual and the environment that is largely dependent on the meaning given to the stimulus by the perceiver. One of the many causes of stress are poor communication skills. SUBJECTS AND METHODS: The aim of the study was to xplain why respondents drop out of research. The project was originally supposed to take place over a period of two years and involve a minimum of 30 respondents per group (30 skippers and 30 seafarers) who would take part in the research for at least four weeks while on board, or during the skipper season. Activity was to be measured with the Polar A370 fitness tracker, worn as a wrist-watch or bracelet and used for 24-hour heart rate, bodily activity and sleep pattern tracking for every respondent. The other device used is TANITA MC780MA, which is a segmental body composition analyser. RESULTS: We contacted overall 146 seafarers, of whom: 40 (27.4%) skippers, 43 (29.5%) deck officers and 63 (43.1%) engine officers. Participation was refused by 18 (12.3% of all contacted) individuals and 108 (74.0%) respondents dropped out during the research. Due to group dispersal and a low number of respondents who reached the end of the research, the project will have to be prolonged. CONCLUSION: We believe that the reasons behind respondent dispersal can be found in their inability to recognize the state they are in and in poor communication skills, while at the same time being exposed to extreme and possibly precarious work conditions. This forms a closed loop that only continues to generate even higher stress levels. Further research is needed to look into this phenomenon.


Assuntos
Ocupações , Pacientes Desistentes do Tratamento , Estresse Psicológico , Frequência Cardíaca , Humanos , Sujeitos da Pesquisa , Navios
4.
Medicine (Baltimore) ; 99(39): e22344, 2020 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-32991449

RESUMO

BACKGROUND: Depression is a disease with a high incidence and easy to relapse. It not only affects the work and life of patients, but also brings a heavy economic burden. University is the peak of depression, and the prevalence of depression among college students is much higher than that of ordinary people. The purpose of this research is to evaluate depression symptoms, life satisfaction, self-confidence, substance use, social adjustment, and dropout rates of the use of psychological intervention for college students. METHODS: We will identify relevant trials from systematic searches in the following electronic databases: PubMed, Embase, Web of Science and The Cochrane Library. We will also search Clinical Trials.gov, the WHO International Clinical Trials Registry Platform for unpublished data. Additional relevant studies will be searched through search engines (such as Google), and references included in the literature will be tracked. All relevant randomized controlled trials (RCTs) will be included. There are no date restrictions. Use Cochrane Collaboration's Risk of bias tool to conduct risk of bias analysis. Use the Grades of Recommendation, Assessment, Development, and Evaluation to assess the quality of evidence. All statistical analysis will be performed using Stata (V.15.0.) and Review Manager (V.5.2.0). RESULTS: A total of 6238 records were obtained by searching the database and 27 records were obtained by other sources. After removing duplicate records, there are 4225 records remaining. We excluded 3945 records through abstract and title, leaving 280 full-text articles. CONCLUSION: This will be the first study to compare the effects of different psychological treatments on depression in college students. We hope that this study will guide clinical decision-making of psychotherapy to better treat depression in college students. PROTOCOL REGISTRATION: INPLASY202070134.


Assuntos
Depressão/terapia , Psicoterapia/métodos , Estudantes/psicologia , Adolescente , Adulto , Depressão/epidemiologia , Depressão/psicologia , Feminino , Carga Global da Doença/economia , Humanos , Incidência , Masculino , Metanálise em Rede , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Satisfação Pessoal , Prevalência , Psicoterapia/tendências , Qualidade de Vida/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Autoimagem , Ajustamento Social , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Universidades , Adulto Jovem
5.
Cochrane Database Syst Rev ; 9: CD012417, 2020 09 08.
Artigo em Inglês | MEDLINE | ID: mdl-32897548

RESUMO

BACKGROUND: People living in 'humanitarian settings' in low- and middle-income countries (LMICs) are exposed to a constellation of physical and psychological stressors that make them vulnerable to developing mental disorders. A range of psychological and social interventions have been implemented with the aim to prevent the onset of mental disorders and/or lower psychological distress in populations at risk, and it is not known whether interventions are effective. OBJECTIVES: To compare the efficacy and acceptability of psychological and social interventions versus control conditions (wait list, treatment as usual, attention placebo, psychological placebo, or no treatment) aimed at preventing the onset of non-psychotic mental disorders in people living in LMICs affected by humanitarian crises. SEARCH METHODS: We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMD-CTR), the Cochrane Drugs and Alcohol Review Group (CDAG) Specialized Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OVID), Embase (OVID), PsycINFO (OVID), and ProQuest PILOTS database with results incorporated from searches to February 2020. We also searched the World Health Organization's (WHO) International Clinical Trials Registry Platform and ClinicalTrials.gov to identify unpublished or ongoing studies. We checked the reference lists of relevant studies and reviews. SELECTION CRITERIA: All randomised controlled trials (RCTs) comparing psychological and social interventions versus control conditions to prevent the onset of mental disorders in adults and children living in LMICs affected by humanitarian crises. We excluded studies that enrolled participants based on a positive diagnosis of mental disorder (or based on a proxy of scoring above a cut-off score on a screening measure). DATA COLLECTION AND ANALYSIS: We calculated standardised mean differences for continuous outcomes and risk ratios for dichotomous data, using a random-effects model. We analysed data at endpoint (zero to four weeks after therapy) and at medium term (one to four months after intervention). No data were available at long term (six months or longer). We used GRADE to assess the quality of evidence. MAIN RESULTS: In the present review we included seven RCTs with a total of 2398 participants, coming from both children/adolescents (five RCTs), and adults (two RCTs). Together, the seven RCTs compared six different psychosocial interventions against a control comparator (waiting list in all studies). All the interventions were delivered by paraprofessionals and, with the exception of one study, delivered at a group level. None of the included studies provided data on the efficacy of interventions to prevent the onset of mental disorders (incidence). For the primary outcome of acceptability, there may be no evidence of a difference between psychological and social interventions and control at endpoint for children and adolescents (RR 0.93, 95% CI 0.78 to 1.10; 5 studies, 1372 participants; low-quality evidence) or adults (RR 0.96, 95% CI 0.61 to 1.50; 2 studies, 767 participants; very low quality evidence). No information on adverse events related to the interventions was available. For children's and adolescents' secondary outcomes of prevention interventions, there may be no evidence of a difference between psychological and social intervention groups and control groups for reducing PTSD symptoms (standardised mean difference (SMD) -0.16, 95% CI -0.50 to 0.18; 3 studies, 590 participants; very low quality evidence), depressive symptoms (SMD -0.01, 95% CI -0.29 to 0.31; 4 RCTs, 746 participants; very low quality evidence) and anxiety symptoms (SMD 0.11, 95% CI -0.09 to 0.31; 3 studies, 632 participants; very low quality evidence) at study endpoint. In adults' secondary outcomes of prevention interventions, psychological counselling may be effective for reducing depressive symptoms (MD -7.50, 95% CI -9.19 to -5.81; 1 study, 258 participants; very low quality evidence) and anxiety symptoms (MD -6.10, 95% CI -7.57 to -4.63; 1 study, 258 participants; very low quality evidence) at endpoint. No data were available for PTSD symptoms in the adult population. Owing to the small number of RCTs included in the present review, it was not possible to carry out neither sensitivity nor subgroup analyses. AUTHORS' CONCLUSIONS: Of the seven prevention studies included in this review, none assessed whether prevention interventions reduced the incidence of mental disorders and there may be no evidence for any differences in acceptability. Additionally, for both child and adolescent populations and adult populations, a very small number of RCTs with low quality evidence on the review's secondary outcomes (changes in symptomatology at endpoint) did not suggest any beneficial effect for the studied prevention interventions. Confidence in the findings is hampered by the scarcity of prevention studies eligible for inclusion in the review, by risk of bias in the studies, and by substantial levels of heterogeneity. Moreover, it is possible that random error had a role in distorting results, and that a more thorough picture of the efficacy of prevention interventions will be provided by future studies. For this reason, prevention studies are urgently needed to assess the impact of interventions on the incidence of mental disorders in children and adults, with extended periods of follow-up.


Assuntos
Países em Desenvolvimento , Transtornos Mentais/prevenção & controle , Psicoterapia , Problemas Sociais/psicologia , Estresse Fisiológico , Estresse Psicológico/complicações , Adolescente , Adulto , Fatores Etários , Ansiedade/diagnóstico , Ansiedade/epidemiologia , Viés , Criança , Depressão/diagnóstico , Depressão/epidemiologia , Países em Desenvolvimento/estatística & dados numéricos , Humanos , Transtornos Mentais/etiologia , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto , Transtornos de Estresse Pós-Traumáticos/diagnóstico , Transtornos de Estresse Pós-Traumáticos/epidemiologia , Listas de Espera
6.
Cochrane Database Syst Rev ; 9: CD010315, 2020 09 09.
Artigo em Inglês | MEDLINE | ID: mdl-32905623

RESUMO

BACKGROUND: This is the second update of the review first published in 2017. Hypertension is a prominent preventable cause of premature morbidity and mortality. People with hypertension and established cardiovascular disease are at particularly high risk, so reducing blood pressure to below standard targets may be beneficial. This strategy could reduce cardiovascular mortality and morbidity but could also increase adverse events. The optimal blood pressure target in people with hypertension and established cardiovascular disease remains unknown. OBJECTIVES: To determine if lower blood pressure targets (135/85 mmHg or less) are associated with reduction in mortality and morbidity as compared with standard blood pressure targets (140 to 160/90 to 100 mmHg or less) in the treatment of people with hypertension and a history of cardiovascular disease (myocardial infarction, angina, stroke, peripheral vascular occlusive disease). SEARCH METHODS: For this updated review, the Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials (RCTs) up to November 2019: Cochrane Hypertension Specialised Register, CENTRAL, MEDLINE (from 1946), Embase (from 1974), and Latin American Caribbean Health Sciences Literature (LILACS) (from 1982), along with the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov. We also contacted authors of relevant papers regarding further published and unpublished work. We applied no language restrictions. SELECTION CRITERIA: We included RCTs with more than 50 participants per group that provided at least six months' follow-up. Trial reports had to present data for at least one primary outcome (total mortality, serious adverse events, total cardiovascular events, cardiovascular mortality). Eligible interventions involved lower targets for systolic/diastolic blood pressure (135/85 mmHg or less) compared with standard targets for blood pressure (140 to 160/90 to 100 mmHg or less). Participants were adults with documented hypertension and adults receiving treatment for hypertension with a cardiovascular history for myocardial infarction, stroke, chronic peripheral vascular occlusive disease, or angina pectoris. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed search results and extracted data using standard methodological procedures expected by Cochrane. We used GRADE to assess the quality of the evidence. MAIN RESULTS: We included six RCTs that involved 9484 participants. Mean follow-up was 3.7 years (range 1.0 to 4.7 years). All RCTs provided individual participant data. None of the included studies was blinded to participants or clinicians because of the need to titrate antihypertensives to reach a specific blood pressure goal. However, an independent committee blinded to group allocation assessed clinical events in all trials. Hence, we assessed all trials at high risk of performance bias and low risk of detection bias. Other issues such as early termination of studies and subgroups of participants not predefined were also considered to downgrade the quality evidence. We found there is probably little to no difference in total mortality (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.91 to 1.23; 6 studies, 9484 participants; moderate-quality evidence) or cardiovascular mortality (RR 1.03, 95% CI 0.82 to 1.29; 6 studies, 9484 participants; moderate-quality evidence). Similarly, we found there may be little to no differences in serious adverse events (RR 1.01, 95% CI 0.94 to 1.08; 6 studies, 9484 participants; low-quality evidence) or total cardiovascular events (including myocardial infarction, stroke, sudden death, hospitalization, or death from congestive heart failure) (RR 0.89, 95% CI 0.80 to 1.00; 6 studies, 9484 participants; low-quality evidence). The evidence was very uncertain about withdrawals due to adverse effects. However, studies suggest more participants may withdraw due to adverse effects in the lower target group (RR 8.16, 95% CI 2.06 to 32.28; 2 studies, 690 participants; very low-quality evidence). Systolic and diastolic blood pressure readings were lower in the lower target group (systolic: mean difference (MD) -8.90 mmHg, 95% CI -13.24 to -4.56; 6 studies, 8546 participants; diastolic: MD -4.50 mmHg, 95% CI -6.35 to -2.65; 6 studies, 8546 participants). More drugs were needed in the lower target group (MD 0.56, 95% CI 0.16 to 0.96; 5 studies, 7910 participants), but blood pressure targets were achieved more frequently in the standard target group (RR 1.21, 95% CI 1.17 to 1.24; 6 studies, 8588 participants). AUTHORS' CONCLUSIONS: We found there is probably little to no difference in total mortality and cardiovascular mortality between people with hypertension and cardiovascular disease treated to a lower compared to a standard blood pressure target. There may also be little to no difference in serious adverse events or total cardiovascular events. This suggests that no net health benefit is derived from a lower systolic blood pressure target. We found very limited evidence on withdrawals due to adverse effects, which led to high uncertainty. At present, evidence is insufficient to justify lower blood pressure targets (135/85 mmHg or less) in people with hypertension and established cardiovascular disease. Several trials are still ongoing, which may provide an important input to this topic in the near future.


Assuntos
Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/efeitos dos fármacos , Doenças Cardiovasculares/tratamento farmacológico , Hipertensão/tratamento farmacológico , Anti-Hipertensivos/efeitos adversos , Viés , Pressão Sanguínea/fisiologia , Doenças Cardiovasculares/mortalidade , Diástole , Humanos , Hipertensão/complicações , Hipertensão/mortalidade , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto , Valores de Referência , Sístole
7.
Cochrane Database Syst Rev ; 9: CD012658, 2020 09 06.
Artigo em Inglês | MEDLINE | ID: mdl-32909630

RESUMO

BACKGROUND: In the absence of treatment, endometrial hyperplasia (EH) can progress to endometrial cancer, particularly in the presence of histologic nuclear atypia. The development of EH results from exposure of the endometrium to oestrogen unopposed by progesterone. Oral progestogens have been used as treatment for EH without atypia, and in some cases of EH with atypia in women who wish to preserve fertility or who cannot tolerate surgery. EH without atypia is associated with a low risk of progression to atypia and cancer; EH with atypia is where the cells are structurally abnormal, and has a higher risk of developing cancer. Oral progestogen is not always effective at reversing the hyperplasia, can be associated with side effects, and depends on patient adherence. The levonorgestrel-intrauterine system (LNG-IUS) is an alternative method of administration of progestogen and may have some advantages over non-intrauterine progestogens. OBJECTIVES: To evaluate the effectiveness and safety of the levonorgestrel intrauterine system (LNG-IUS) in women with endometrial hyperplasia (EH) with or without atypia compared to medical treatment with non-intrauterine progestogens, placebo, surgery or no treatment. SEARCH METHODS: We searched the following databases: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO, and conference proceedings of 10 relevant organisations. We handsearched references in relevant published studies. We also searched ongoing trials in ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry, and other trial registries. We performed the final search in May 2020. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cross-over trials of women with a histological diagnosis of endometrial hyperplasia with or without atypia comparing LNG-IUS with non-intrauterine progestogens, placebo, surgery or no treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment and data extraction. Our primary outcome measures were regression of EH and adverse effects associated with the LNG-IUS device (such as pelvic inflammatory disease, device expulsion, uterine perforation) when compared to treatment with non-intrauterine progestogens, placebo, surgery or no treatment. Secondary outcomes included hysterectomy, hormone-related adverse effects (such as bleeding/spotting, pelvic pain, breast tenderness, ovarian cysts, weight gain, acne), withdrawal from treatment due to adverse effects, satisfaction with treatment, and cost or resource use. We rated the overall quality of evidence using GRADE methods. MAIN RESULTS: Thirteen RCTs (1657 women aged 22 to 75 years) met the inclusion criteria. Two studies had insufficient data for meta-analysis, thus the quantitative analysis included 11 RCTs. All trials evaluated treatment duration of six months or less. The evidence ranged from very low to moderate quality: the main limitations were risk of bias (associated with lack of blinding and poor reporting of study methods), inconsistency and imprecision. LNG-IUS versus non-intrauterine progestogens Primary outcomes Regression of endometrial hyperplasia The LNG-IUS probably improves regression of EH compared with non-intrauterine progestogens at short-term follow-up (up to six months) (OR 2.94, 95% CI 2.10 to 4.13; I² = 0%; 10 RCTs, 1108 participants; moderate-quality evidence). This suggests that if regression of EH following treatment with a non-intrauterine progestogen is assumed to be 72%, regression of EH following treatment with LNG-IUS would be between 85% and 92%. Regression of EH may be improved by LNG-IUS compared with non-intrauterine progestogens at long-term follow-up (12 months) (OR 3.80, 95% CI 1.75 to 8.23; 1 RCT, 138 participants; low-quality evidence), Adverse effects associated with LNG-IUS There was insufficient evidence to determine device-related adverse effects; only one study reported on expulsion with insufficient data for analysis. Secondary outcomes The LNG-IUS may be associated with fewer hysterectomies (OR 0.26, 95% CI 0.15 to 0.46; I² = 19%; 4 RCTs, 452 participants; low-quality evidence), fewer withdrawals from treatment due to hormone-related adverse effects (OR 0.41, 95% CI 0.12 to 1.35; I² = 0%; 4 RCTs, 360 participants; low-quality evidence) and improved patient satisfaction with treatment (OR 5.28, 95% CI 2.51 to 11.10; I² = 0%; 2 RCTs, 202 participants; very low-quality evidence) compared to non-intrauterine progestogens. The LNG-IUS may be associated with more bleeding/spotting (OR 2.13, 95% CI 1.33 to 3.43; I² = 78%; 3 RCTs, 428 participants) and less nausea (OR 0.52, 95% CI 0.28 to 0.95; I² = 0%; 3 RCTs, 428 participants) compared to non-intrauterine progestogens. Data from single trials for mood swings and fatigue had a similar direction of effect as for bleeding/spotting, nausea and weight gain. There was insufficient evidence to determine cost or resource use. LNG-IUS versus no treatment Regression of endometrial hyperplasia One study demonstrated that the LNG-IUS is associated with regression of EH without atypia (OR 78.41, 95% CI 22.86 to 268.97; I² = 0%; 1 RCT, 190 participants; moderate-quality evidence) compared with no treatment. This study did not report on any other review outcome. AUTHORS' CONCLUSIONS: There is moderate-quality evidence that treatment with LNG-IUS used for three to six months is probably more effective than non-intrauterine progestogens at reversing EH in the short term (up to six months) and long term (up to two years). Adverse effects (device-related and hormone-related) were poorly and incompletely reported across studies. Very low quality to low-quality evidence suggests the LNG-IUS may reduce the risk of hysterectomy, and may be associated with more bleeding/spotting, less nausea, less withdrawal from treatment due to adverse effects, and increased satisfaction with treatment, compared to non-intrauterine progestogens. There was insufficient evidence to reach conclusions regarding device-related adverse effects, or cost or resource use.


Assuntos
Anticoncepcionais Femininos/administração & dosagem , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Adulto , Idoso , Viés , Anticoncepcionais Femininos/efeitos adversos , Hiperplasia Endometrial/tratamento farmacológico , Hiperplasia Endometrial/patologia , Hiperplasia Endometrial/cirurgia , Feminino , Humanos , Histerectomia/estatística & dados numéricos , Expulsão de Dispositivo Intrauterino , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/efeitos adversos , Pessoa de Meia-Idade , Náusea/etiologia , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Satisfação do Paciente/estatística & dados numéricos , Progestinas/administração & dosagem , Progestinas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão , Fatores de Tempo , Hemorragia Uterina/etiologia , Ganho de Peso , Adulto Jovem
8.
Cochrane Database Syst Rev ; 9: CD008652, 2020 09 02.
Artigo em Inglês | MEDLINE | ID: mdl-32877573

RESUMO

BACKGROUND: This is the second update of this systematic review. High blood pressure represents a major public health problem. Worldwide, approximately one-fourth of the adult population has hypertension. Epidemiological and experimental studies suggest a link between hyperuricaemia and hypertension. Hyperuricaemia affects 25% to 40% of those with untreated hypertension; a much lower prevalence has been reported in those with normotension or in the general population. However, whether lowering serum uric acid (UA) might lower blood pressure (BP), is an unanswered question. OBJECTIVES: To determine whether UA-lowering agents reduce BP in people with primary hypertension or prehypertension, compared with placebo. SEARCH METHODS: The Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to May 2020: the Cochrane Hypertension Specialised Register, CENTRAL 2018, Issue 12, MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also searched LILACS (1982 to May 2020), and contacted authors of relevant papers regarding further published and unpublished work. The searches had no language or date restrictions. SELECTION CRITERIA: To be included in this updated review, the studies had to meet the following criteria: 1) randomised or quasi-randomised, with a group assigned to receive a UA-lowering agent and another group assigned to receive placebo; 2) double-blind, single-blind, or open-label; 3) parallel or cross-over trial design; 4) cross-over trials had to have a washout period of at least two weeks; 5) minimum treatment duration of four weeks; 6) participants had to have a diagnosis of essential hypertension or prehypertension plus hyperuricaemia (serum UA greater than 6 mg/dL in women, 7 mg/dL in men, and 5.5 mg/dL in children or adolescents); 7) outcome measures included change in 24-hour ambulatory systolic or diastolic BP, or both; or clinic-measured systolic or diastolic BP, or both. DATA COLLECTION AND ANALYSIS: The two review authors independently collected the data using a data extraction form, and resolved any disagreements via discussion. We assessed risk of bias using the Cochrane 'Risk of bias' tool. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: In this review update, we screened 722 records, selected 26 full-text reports for evaluation. We identified no ongoing studies and did not add any new studies. We included three randomised controlled trials (RCTs), enrolling 211 people with hypertension or prehypertension, plus hyperuricaemia. Low-certainty evidence from three RCTs found inconclusive results between those who received UA-lowering drugs and placebo, in 24-hour ambulatory systolic (MD -6.2 mmHg, 95% CI -12.8 to 0.5) or diastolic BP (-3.9 mmHg, 95% CI -9.2 to 1.4). Low-certainty evidence from two RCTs found that UA-lowering drugs reduced clinic-measured systolic BP (-8.43 mmHg, 95% CI -15.24 to -1.62) but results for clinic-measured diastolic BP were inconclusive (-6.45 mmHg, 95% CI -13.60 to 0.70). High-certainty evidence from three RCTs found that serum UA levels were reduced by 3.1 mg/dL (95% CI 2.4 to 3.8) in the participants that received UA-lowering drugs. Low-certainty evidence from three RCTs found inconclusive results regarding the occurrence of adverse events between those who received UA-lowering drugs and placebo (RR 1.86, 95% CI 0.43 to 8.10). AUTHORS' CONCLUSIONS: In this updated Cochrane Review, the current RCT data are insufficient to know whether UA-lowering therapy lowers BP. More studies are needed.


Assuntos
Alopurinol/uso terapêutico , Hipertensão/tratamento farmacológico , Hiperuricemia/tratamento farmacológico , Uricosúricos/uso terapêutico , Adolescente , Adulto , Pressão Sanguínea/efeitos dos fármacos , Criança , Humanos , Hipertensão/complicações , Hiperuricemia/complicações , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Placebos/uso terapêutico , Pré-Hipertensão/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto
9.
Cochrane Database Syst Rev ; 8: CD000543, 2020 08 12.
Artigo em Inglês | MEDLINE | ID: mdl-32786164

RESUMO

BACKGROUND: Oral 5-aminosalicylic acid (5-ASA) preparations were intended to avoid the adverse effects of sulfasalazine (SASP) while maintaining its therapeutic benefits. It was previously found that 5-ASA drugs in doses of at least 2 g/day were more effective than placebo but no more effective than SASP for inducing remission in ulcerative colitis (UC). This review is an update of a previously published Cochrane Review. OBJECTIVES: To assess the efficacy, dose-responsiveness and safety of oral 5-ASA compared to placebo, SASP, or 5-ASA comparators (i.e. other formulations of 5-ASA) for induction of remission in active UC. A secondary objective was to compare the efficacy and safety of once-daily dosing of oral 5-ASA versus conventional dosing regimens (two or three times daily). SEARCH METHODS: We searched MEDLINE, Embase and the Cochrane Library on 11 June 2019. We also searched references, conference proceedings and study registers to identify additional studies. SELECTION CRITERIA: We considered randomized controlled trials (RCTs) including adults (aged 18 years or more) with active UC for inclusion. We included studies that compared oral 5-ASA therapy with placebo, SASP, or other 5-ASA formulations. We also included studies that compared once-daily to conventional dosing as well as dose-ranging studies. DATA COLLECTION AND ANALYSIS: Outcomes include failure to induce global/clinical remission, global/clinical improvement, endoscopic remission, endoscopic improvement, adherence, adverse events (AEs), serious adverse events (SAEs), withdrawals due to AEs, and withdrawals or exclusions after entry. We analyzed five comparisons: 5-ASA versus placebo, 5-ASA versus sulfasalazine, once-daily dosing versus conventional dosing, 5-ASA (e.g. MMX mesalamine, Ipocol, Balsalazide, Pentasa, Olsalazine and 5-ASA micropellets) versus comparator 5-ASA (e.g. Asacol, Claversal, Salofalk), and 5-ASA dose-ranging. We calculated the risk ratio (RR) and 95% confidence interval (95% CI) for each outcome. We analyzed data on an intention-to-treat basis, and used GRADE to assess the overall certainty of the evidence. MAIN RESULTS: We include 54 studies (9612 participants). We rated most studies at low risk of bias. Seventy-one per cent (1107/1550) of 5-ASA participants failed to enter clinical remission compared to 83% (695/837) of placebo participants (RR 0.86, 95% CI 0.82 to 0.89; 2387 participants, 11 studies; high-certainty evidence). We also observed a dose-response trend for 5-ASA. There was no difference in clinical remission rates between 5-ASA and SASP. Fifty-four per cent (150/279) of 5-ASA participants failed to enter remission compared to 58% (144/247) of SASP participants (RR 0.90, 95% CI 0.77 to 1.04; 526 participants, 8 studies; moderate-certainty evidence). There was no difference in remission rates between once-daily dosing and conventional dosing. Sixty per cent (533/881) of once-daily participants failed to enter clinical remission compared to 61% (538/880) of conventionally-dosed participants (RR 0.99, 95% CI 0.93 to 1.06; 1761 participants, 5 studies; high-certainty evidence). Eight per cent (15/179) of participants dosed once daily failed to adhere to their medication regimen compared to 6% (11/179) of conventionally-dosed participants (RR 1.36, 95% CI 0.64 to 2.86; 358 participants, 2 studies; low-certainty evidence). There does not appear to be any difference in efficacy among the various 5-ASA formulations. Fifty per cent (507/1022) of participants in the 5-ASA group failed to enter remission compared to 52% (491/946) of participants in the 5-ASA comparator group (RR 0.94, 95% CI 0.86 to 1.02; 1968 participants, 11 studies; moderate-certainty evidence). There was no evidence of a difference in the incidence of adverse events and serious adverse events between 5-ASA and placebo, once-daily and conventionally-dosed 5-ASA, and 5-ASA and comparator 5-ASA formulation studies. Common adverse events included flatulence, abdominal pain, nausea, diarrhea, headache and worsening UC. SASP was not as well tolerated as 5-ASA. Twenty-nine per cent (118/411) of SASP participants experienced an AE compared to 15% (72/498) of 5-ASA participants (RR 0.48, 95% CI 0.36 to 0.63; 909 participants, 12 studies; moderate-certainty evidence). AUTHORS' CONCLUSIONS: There is high-certainty evidence that 5-ASA is superior to placebo, and moderate-certainty evidence that 5-ASA is not more effective than SASP. Considering relative costs, a clinical advantage to using oral 5-ASA in place of SASP appears unlikely. High-certainty evidence suggests 5-ASA dosed once daily appears to be as efficacious as conventionally-dosed 5-ASA. There may be little or no difference in efficacy or safety among the various 5-ASA formulations.


Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Colite Ulcerativa/tratamento farmacológico , Mesalamina/administração & dosagem , Sulfassalazina/administração & dosagem , Administração Oral , Anti-Inflamatórios não Esteroides/efeitos adversos , Viés , Esquema de Medicação , Humanos , Quimioterapia de Indução/métodos , Mesalamina/efeitos adversos , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Placebos/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão , Sulfassalazina/efeitos adversos , Falha de Tratamento
10.
Cochrane Database Syst Rev ; 8: CD000544, 2020 08 28.
Artigo em Inglês | MEDLINE | ID: mdl-32856298

RESUMO

BACKGROUND: Oral 5-aminosalicylic acid (5-ASA; also known as mesalazine or mesalamine) preparations were intended to avoid the adverse effects of sulfasalazine (SASP) while maintaining its therapeutic benefits. In an earlier version of this review, we found that 5-ASA drugs were more effective than placebo for maintenance of remission of ulcerative colitis (UC), but had a significant therapeutic inferiority relative to SASP. In this version, we have rerun the search to bring the review up to date. OBJECTIVES: To assess the efficacy, dose-responsiveness, and safety of oral 5-ASA compared to placebo, SASP, or 5-ASA comparators for maintenance of remission in quiescent UC and to compare the efficacy and safety of once-daily dosing of oral 5-ASA with conventional (two or three times daily) dosing regimens. SEARCH METHODS: We performed a literature search for studies on 11 June 2019 using MEDLINE, Embase, and the Cochrane Library. In addition, we searched review articles and conference proceedings. SELECTION CRITERIA: We included randomized controlled trials with a minimum treatment duration of six months. We considered studies of oral 5-ASA therapy for treatment of participants with quiescent UC compared with placebo, SASP, or other 5-ASA formulations. We also included studies that compared once-daily 5-ASA treatment with conventional dosing of 5-ASA and 5-ASA dose-ranging studies. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. The primary outcome was the failure to maintain clinical or endoscopic remission. Secondary outcomes were adherence, adverse events (AE), serious adverse events (SAE), withdrawals due to AEs, and withdrawals or exclusions after entry. Trials were separated into five comparison groups: 5-ASA versus placebo, 5-ASA versus SASP, once-daily dosing versus conventional dosing, 5-ASA (balsalazide, Pentasa, and olsalazine) versus comparator 5-ASA formulation (Asacol and Salofalk), and 5-ASA dose-ranging. We calculated the risk ratio (RR) and 95% confidence interval (CI) for each outcome. We analyzed data on an intention-to-treat basis, and used GRADE to assess the overall certainty of the evidence. MAIN RESULTS: The search identified 44 studies (9967 participants). Most studies were at low risk of bias. Ten studies were at high risk of bias. Seven of these studies were single-blind and three were open-label. 5-ASA is more effective than placebo for maintenance of clinical or endoscopic remission. About 37% (335/907) of 5-ASA participants relapsed at six to 12 months compared to 55% (355/648) of placebo participants (RR 0.68, 95% CI 0.61 to 0.76; 8 studies, 1555 participants; high-certainty evidence). Adherence to study medication was not reported for this comparison. SAEs were reported in 1% (6/550) of participants in the 5-ASA group compared to 2% (5/276) of participants in the placebo group at six to 12 months (RR 0.60, 95% CI 0.19 to 1.84; 3 studies, 826 participants; low-certainty evidence). There is probably little or no difference in AEs at six to 12 months' follow-up (RR 0.93, 95% CI 0.73 to 1.18; 5 studies, 1132 participants; moderate-certainty evidence). SASP is more effective than 5-ASA for maintenance of remission. About 48% (416/871) of 5-ASA participants relapsed at six to 18 months compared to 43% (336/784) of SASP participants (RR 1.14, 95% CI 1.03 to 1.27; 12 studies, 1655 participants; high-certainty evidence). Adherence to study medication and SAEs were not reported for this comparison. There is probably little or no difference in AEs at six to 12 months' follow-up (RR 1.07, 95% CI 0.82 to 1.40; 7 studies, 1138 participants; moderate-certainty evidence). There is little or no difference in clinical or endoscopic remission rates between once-daily and conventionally dosed 5-ASA. About 37% (717/1939) of once-daily participants relapsed over 12 months compared to 39% (770/1971) of conventional-dosing participants (RR 0.94, 95% CI 0.88 to 1.01; 10 studies, 3910 participants; high-certainty evidence). There is probably little or no difference in medication adherence rates. About 10% (106/1152) of participants in the once-daily group failed to adhere to their medication regimen compared to 8% (84/1154) of participants in the conventional-dosing group (RR 1.18, 95% CI 0.72 to 1.93; 9 studies, 2306 participants; moderate-certainty evidence). About 3% (41/1587) of participants in the once-daily group experienced a SAE compared to 2% (35/1609) of participants in the conventional-dose group at six to 12 months (RR 1.20, 95% CI 0.77 to 1.87; moderate-certainty evidence). There is little or no difference in the incidence of AEs at six to 13 months' follow-up (RR 0.98, 95% CI 0.92 to 1.04; 8 studies, 3497 participants; high-certainty evidence). There may be little or no difference in the efficacy of different 5-ASA formulations. About 44% (158/358) of participants in the 5-ASA group relapsed at six to 18 months compared to 41% (142/349) of participants in the 5-ASA comparator group (RR 1.08, 95% CI 0.91 to 1.28; 6 studies, 707 participants; low-certainty evidence). AUTHORS' CONCLUSIONS: There is high-certainty evidence that 5-ASA is superior to placebo for maintenance therapy in UC. There is high-certainty evidence that 5-ASA is inferior compared to SASP. There is probably little or no difference between 5-ASA and placebo, and 5-ASA and SASP in commonly reported AEs such as flatulence, abdominal pain, nausea, diarrhea, headache, and dyspepsia. Oral 5-ASA administered once daily has a similar benefit and harm profile as conventional dosing for maintenance of remission in quiescent UC.


Assuntos
Ácidos Aminossalicílicos/administração & dosagem , Anti-Inflamatórios não Esteroides/administração & dosagem , Colite Ulcerativa/tratamento farmacológico , Quimioterapia de Manutenção/métodos , Mesalamina/administração & dosagem , Administração Oral , Anti-Inflamatórios não Esteroides/efeitos adversos , Viés , Colite Ulcerativa/prevenção & controle , Esquema de Medicação , Humanos , Adesão à Medicação/estatística & dados numéricos , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Placebos/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Indução de Remissão/métodos , Sulfassalazina/administração & dosagem , Sulfassalazina/efeitos adversos
11.
Cochrane Database Syst Rev ; 8: CD008016, 2020 08 11.
Artigo em Inglês | MEDLINE | ID: mdl-32840872

RESUMO

BACKGROUND: The symptoms and signs of schizophrenia have been linked to high levels of dopamine in specific areas of the brain (limbic system). Antipsychotic drugs block the transmission of dopamine in the brain and reduce the acute symptoms of the disorder. An original version of the current review, published in 2012, examined whether antipsychotic drugs are also effective for relapse prevention. This is the updated version of the aforesaid review. OBJECTIVES: To review the effects of maintaining antipsychotic drugs for people with schizophrenia compared to withdrawing these agents. SEARCH METHODS: We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials including the registries of clinical trials (12 November 2008, 10 October 2017, 3 July 2018, 11 September 2019). SELECTION CRITERIA: We included all randomised trials comparing maintenance treatment with antipsychotic drugs and placebo for people with schizophrenia or schizophrenia-like psychoses. DATA COLLECTION AND ANALYSIS: We extracted data independently. For dichotomous data we calculated risk ratios (RR) and their 95% confidence intervals (CIs) on an intention-to-treat basis based on a random-effects model. For continuous data, we calculated mean differences (MD) or standardised mean differences (SMD), again based on a random-effects model. MAIN RESULTS: The review currently includes 75 randomised controlled trials (RCTs) involving 9145 participants comparing antipsychotic medication with placebo. The trials were published from 1959 to 2017 and their size ranged between 14 and 420 participants. In many studies the methods of randomisation, allocation and blinding were poorly reported. However, restricting the analysis to studies at low risk of bias gave similar results. Although this and other potential sources of bias limited the overall quality, the efficacy of antipsychotic drugs for maintenance treatment in schizophrenia was clear. Antipsychotic drugs were more effective than placebo in preventing relapse at seven to 12 months (primary outcome; drug 24% versus placebo 61%, 30 RCTs, n = 4249, RR 0.38, 95% CI 0.32 to 0.45, number needed to treat for an additional beneficial outcome (NNTB) 3, 95% CI 2 to 3; high-certainty evidence). Hospitalisation was also reduced, however, the baseline risk was lower (drug 7% versus placebo 18%, 21 RCTs, n = 3558, RR 0.43, 95% CI 0.32 to 0.57, NNTB 8, 95% CI 6 to 14; high-certainty evidence). More participants in the placebo group than in the antipsychotic drug group left the studies early due to any reason (at seven to 12 months: drug 36% versus placebo 62%, 24 RCTs, n = 3951, RR 0.56, 95% CI 0.48 to 0.65, NNTB 4, 95% CI 3 to 5; high-certainty evidence) and due to inefficacy of treatment (at seven to 12 months: drug 18% versus placebo 46%, 24 RCTs, n = 3951, RR 0.37, 95% CI 0.31 to 0.44, NNTB 3, 95% CI 3 to 4). Quality of life might be better in drug-treated participants (7 RCTs, n = 1573 SMD -0.32, 95% CI to -0.57 to -0.07; low-certainty evidence); probably the same for social functioning (15 RCTs, n = 3588, SMD -0.43, 95% CI -0.53 to -0.34; moderate-certainty evidence). Underpowered data revealed no evidence of a difference between groups for the outcome 'Death due to suicide' (drug 0.04% versus placebo 0.1%, 19 RCTs, n = 4634, RR 0.60, 95% CI 0.12 to 2.97,low-certainty evidence) and for the number of participants in employment (at 9 to 15 months, drug 39% versus placebo 34%, 3 RCTs, n = 593, RR 1.08, 95% CI 0.82 to 1.41, low certainty evidence). Antipsychotic drugs (as a group and irrespective of duration) were associated with more participants experiencing movement disorders (e.g. at least one movement disorder: drug 14% versus placebo 8%, 29 RCTs, n = 5276, RR 1.52, 95% CI 1.25 to 1.85, number needed to treat for an additional harmful outcome (NNTH) 20, 95% CI 14 to 50), sedation (drug 8% versus placebo 5%, 18 RCTs, n = 4078, RR 1.52, 95% CI 1.24 to 1.86, NNTH 50, 95% CI not significant), and weight gain (drug 9% versus placebo 6%, 19 RCTs, n = 4767, RR 1.69, 95% CI 1.21 to 2.35, NNTH 25, 95% CI 20 to 50). AUTHORS' CONCLUSIONS: For people with schizophrenia, the evidence suggests that maintenance on antipsychotic drugs prevents relapse to a much greater extent than placebo for approximately up to two years of follow-up. This effect must be weighed against the adverse effects of antipsychotic drugs. Future studies should better clarify the long-term morbidity and mortality associated with these drugs.


Assuntos
Antipsicóticos/uso terapêutico , Quimioterapia de Manutenção/métodos , Esquizofrenia/prevenção & controle , Antipsicóticos/efeitos adversos , Viés , Antagonistas de Dopamina/efeitos adversos , Antagonistas de Dopamina/uso terapêutico , Emprego/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Humanos , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Placebos/uso terapêutico , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Esquizofrenia/tratamento farmacológico , Prevenção Secundária
12.
PLoS One ; 15(8): e0237061, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32790718

RESUMO

Stepped-care (SC) models for anxiety disorders are implemented on a large scale and are assumed to be as effective for the greater majority of patients as more intensive treatment schemes. To compare the outcomes of SC and international guideline-based treatment (Treatment as Usual: TAU) for panic disorder, a total of 128 patients were randomized to either SC or TAU (ratio 2: 1, respectively) using a computer generated algorithm. They were treated in four mental health care centres in the Netherlands after therapists had been trained in SC by a senior expert therapist. SC comprised 10-week guided self-help (pen-and-paper version) followed, if indicated, by 13-week manualized face-to-face cognitive behavioural therapy (CBT), with medication- if prescribed- kept constant. TAU consisted of 23-week regular face-to-face CBT (RCBT) with medication -when prescribed- also kept constant. The means of the attended sessions in the SC condition was 5.9 (SD = 4.8) for ITT and 9.6 (SD = 9.6) for the RCBT condition. The difference in the number of attended sessions between the conditions was significant (t(126) = -3.87, p < .001). Remission rates between treatment conditions did not differ significantly (SC: 44.5%; RCBT: 53.3%) and symptom reduction was similar. Stepping up SC treatment to face-to-face CBT showed a minimal additional effect. Importantly, drop-out rates differed significantly for the two conditions (SC: 48.2%; RCBT: 26.7%). SC was effective in the treatment of panic disorder in terms of symptom reduction and remission rate, but dropout rates were twice as high as those seen in RCBT, with the second phase of SC not substantially improving treatment response. However, SC required significantly less therapist contact time compared to RCBT, and more research is needed to explore predictors of success for guided self-help interventions to allow treatment intensity to be tailored to patients' needs and preferences.


Assuntos
Terapia Cognitivo-Comportamental/métodos , Transtorno de Pânico/terapia , Autocuidado/métodos , Adulto , Agorafobia/complicações , Agorafobia/tratamento farmacológico , Agorafobia/terapia , Ansiolíticos/uso terapêutico , Terapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Avaliação de Resultados em Cuidados de Saúde , Transtorno de Pânico/complicações , Transtorno de Pânico/tratamento farmacológico , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Resultado do Tratamento , Adulto Jovem
13.
Medicine (Baltimore) ; 99(27): e21099, 2020 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-32629742

RESUMO

RATIONALE: Intramural esophageal squamous cell carcinoma (ESCC) without mucosal invasion is extremely rare. Endoscopic mucosal biopsy results are often negative, making diagnosis difficult. In these cases, endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) biopsy is a useful diagnostic method. PATIENT CONCERNS: A 78-year-old female was admitted to hospital due to dysphagia, and gastroscopy showed a concentric narrowing of the esophageal lumen with a smooth and undamaged esophageal mucosa. DIAGNOSES: Endoscopic ultrasound (EUS) revealed that the esophageal mucosa was thickened with a low echo, and the layers of the esophageal wall could not be clearly distinguished. Cytologic and pathologic diagnoses were obtained through EUS-FNA, which suggested ESCC. INTERVENTIONS: According to the pathologic diagnosis obtained by EUS-FNA, surgery or radiotherapy were recommended for this patient. Eventually, this patient elected to seek treatment at another medical institution. OUTCOMES: This type of disease cannot be diagnosed according to gastroscopic biopsy alone, and the diagnosis was eventually confirmed through EUS-FNA. LESSONS: When an imaging examination suggests a possible malignant lesion of the oesophagus, EUS-FNA may be considered if the surface mucosa contains no endoscopic damage. EUS-FNA has high diagnostic value with high sensitivity, minimal invasiveness, and high safety.


Assuntos
Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/métodos , Neoplasias Esofágicas/patologia , Carcinoma de Células Escamosas do Esôfago/diagnóstico por imagem , Carcinoma de Células Escamosas do Esôfago/patologia , Idoso , Transtornos de Deglutição/diagnóstico , Transtornos de Deglutição/etiologia , Feminino , Gastroscopia/métodos , Hospitalização , Humanos , Membrana Mucosa/patologia , Pacientes Desistentes do Tratamento/psicologia , Radioterapia/normas , Procedimentos Cirúrgicos Operatórios/normas
15.
Rev Bras Epidemiol ; 23: e200079, 2020.
Artigo em Inglês, Português | MEDLINE | ID: mdl-32696931

RESUMO

OBJECTIVE: This study aimed to investigate the factors associated with the outcomes of recovery and abandonment in the incarcerated population with tuberculosis. METHODS: A quantitative and observational analytical study was performed with data from the Notification Disease Information System (Sinan), tuberculosis data from the incarcerated population in the state of Paraiba from 2007 to 2016; Notifications of individuals over the age of 18, reported as "new cases" and the outcome, "recovery" or "abandonment" status were included. Those people who until December 2016 had no outcome information were excluded. Analyses were performed using bivariate and multivariate statistics from the Poisson regression. RESULTS: Of the 614 notifications, most were male (93.8%). In the bivariate analysis, there was a statistically relevant association of outcomes with Acquired Immunodeficiency Syndrome (p = 0.044), Human Immunodeficiency Virus (HIV) serology (p = 0.048) and lack of completion of follow-up bacilloscopy (p = 0.001). In the adjusted multivariate analysis, Acquired Immunodeficiency Syndrome (RR = 1.998; 95%CI 1.078 - 3.704; p = 0.028) and lack of completion of follow-up bacilloscopy (RR = 5.251; 95%CI 2.158 - 12.583; p <0.001*) remained significantly associated with the dropout outcome. CONCLUSION: Recovery and abandonment outcomes were mainly associated with whether the follow-up bacilloscopy was performed or not and Acquired Immunodeficiency Syndrome.


Assuntos
Pacientes Desistentes do Tratamento/estatística & dados numéricos , Prisioneiros/estatística & dados numéricos , Tuberculose/terapia , Síndrome de Imunodeficiência Adquirida/epidemiologia , Adulto , Técnicas Bacteriológicas/estatística & dados numéricos , Brasil/epidemiologia , Feminino , Seguimentos , Humanos , Masculino , Resultado do Tratamento
16.
Cochrane Database Syst Rev ; 7: CD007783, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-32609387

RESUMO

BACKGROUND: This is an update of the Cochrane Review first published in 2010; it includes one additional study. Primary generalised tonic-clonic seizures are a type of generalised seizure. Other types of seizures include: absence, myoclonic, and atonic seizures. Effective control of tonic-clonic seizures reduces the risk of injury and death, and improves quality of life. While most people achieve seizure control with one antiepileptic drug, around 30% do not, and require a combination of antiepileptic drugs. OBJECTIVES: To assess the effectiveness and tolerability of add-on lamotrigine for drug-resistant primary generalised tonic-clonic seizures. SEARCH METHODS: For the latest update, we searched these databases on 19 March 2019: Cochrane Register of Studies (CRS) Web, MEDLINE Ovid, and the WHO International Clinical Trials Registry Platform (ICTRP). The CRS includes records from the Cochrane Epilepsy Group Specialized Register, CENTRAL, Embase, and ClinicalTrials.gov. We imposed no language restrictions. We also contacted GlaxoSmithKline, manufacturers of lamotrigine. SELECTION CRITERIA: Randomised controlled parallel or cross-over trials of add-on lamotrigine for people of any age with drug-resistant primary generalised tonic-clonic seizures. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology; two review authors independently assessed trials for inclusion, evaluated risk of bias, extracted relevant data, and GRADE-assessed evidence. We investigated these outcomes: (1) 50% or greater reduction in primary generalised tonic-clonic seizure frequency; (2) seizure freedom; (3) treatment withdrawal; (4) adverse effects; (5) cognitive effects; and (6) quality of life. We used an intention-to-treat (ITT) population for all analyses, and presented results as risk ratios (RRs) with 95% confidence intervals (CIs); for adverse effects, we used 99% CIs to compensate for multiple hypothesis testing. MAIN RESULTS: We included three studies (total 300 participants): two parallel-group studies and one cross-over study. We assessed varied risks of bias across studies; most limitations arose from the poor reporting of methodological details. We meta-analysed data extracted from the two parallel-group studies, and conducted a narrative synthesis for data from the cross-over study. Both parallel-group studies (270 participants) reported all dichotomous outcomes. Participants taking lamotrigine were almost twice as likely to attain a 50% or greater reduction in primary generalised tonic-clonic seizure frequency than those taking a placebo (RR 1.88, 95% CI 1.43 to 2.45; low-certainty evidence). The results between groups were inconclusive for the likelihood of seizure freedom (RR 1.55, 95% CI 0.89 to 2.72; very low-certainty evidence); treatment withdrawal (RR 1.20, 95% CI 0.72 to 1.99; very low-certainty evidence); and individual adverse effects: ataxia (RR 3.05, 99% CI 0.05 to 199.36); dizziness (RR 0.91, 99% CI 0.29 to 2.86; very low-certainty evidence); fatigue (RR 1.02, 99% CI 0.13 to 8.14; very low-certainty evidence); nausea (RR 1.60, 99% CI 0.48 to 5.32; very low-certainty evidence); and somnolence (RR 3.73, 99% CI 0.36 to 38.90; low-certainty evidence). The cross-over trial (26 participants) reported that 7/14 participants with generalised tonic-clonic seizures experienced a 50% or greater reduction in seizure frequency with add-on lamotrigine compared to placebo. The authors reported four treatment withdrawals, but did not specify during which treatment allocation they occurred. Rash (seven lamotrigine participants; zero placebo participants) and fatigue (five lamotrigine participants; zero placebo participants) were the most frequently reported adverse effects. None of the included studies measured cognition. One parallel-group study (N = 153) evaluated quality of life. They reported inconclusive results for the overall quality of life score between groups (P = 0.74). AUTHORS' CONCLUSIONS: This review provides insufficient information to inform clinical practice. Low-certainty evidence suggests that lamotrigine reduces the rate of generalised tonic-clonic seizures by 50% or more. Very low-certainty evidence found inconclusive results between groups for all other outcomes. Therefore, we are uncertain to very uncertain that the results reported are accurate, and suggest that the true effect could be grossly different. More trials, recruiting larger populations, over longer periods, are necessary to determine lamotrigine's clinical use.


Assuntos
Anticonvulsivantes/uso terapêutico , Epilepsia Resistente a Medicamentos/tratamento farmacológico , Epilepsia Tônico-Clônica/tratamento farmacológico , Lamotrigina/uso terapêutico , Anticonvulsivantes/efeitos adversos , Quimioterapia Adjuvante/métodos , Tontura/induzido quimicamente , Erupção por Droga/etiologia , Exantema/induzido quimicamente , Fadiga/induzido quimicamente , Humanos , Lamotrigina/efeitos adversos , Náusea/induzido quimicamente , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto , Sonolência
17.
Cochrane Database Syst Rev ; 7: CD007026, 2020 07 14.
Artigo em Inglês | MEDLINE | ID: mdl-32662068

RESUMO

BACKGROUND: Cerebrolysin is a mixture of low-molecular-weight peptides and amino acids derived from porcine brain that has potential neuroprotective properties. It is widely used in the treatment of acute ischaemic stroke in Russia, Eastern Europe, China, and other Asian and post-Soviet countries. This is an update of a review first published in 2010 and last updated in 2017. OBJECTIVES: To assess the benefits and harms of Cerebrolysin for treating acute ischaemic stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase, Web of Science Core Collection, with Science Citation Index, LILACS, OpenGrey, and a number of Russian databases in October 2019. We also searched reference lists, ongoing trials registers, and conference proceedings. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing Cerebrolysin, started within 48 hours of stroke onset and continued for any length of time, with placebo or no treatment in people with acute ischaemic stroke. DATA COLLECTION AND ANALYSIS: Two review authors independently applied the inclusion criteria, assessed trial quality and risk of bias, extracted data, and applied GRADE criteria to the evidence. MAIN RESULTS: Seven RCTs (1601 participants) met the inclusion criteria of the review. In this update we re-evaluated risk of bias through identification, examination, and evaluation of study protocols and judged it to be low, unclear, or high across studies: unclear for all domains in one study, and unclear for selective outcome reporting across all studies; low for blinding of participants and personnel in four studies and unclear in the remaining three; low for blinding of outcome assessors in three studies and unclear in four studies. We judged risk of bias to be low in two studies and unclear in the remaining five studies for generation of allocation sequence; low in one study and unclear in six studies for allocation concealment; and low in one study, unclear in one study, and high in the remaining five studies for incomplete outcome data. The manufacturer of Cerebrolysin supported four multicentre studies, either totally, or by providing Cerebrolysin and placebo, randomisation codes, research grants, or statisticians. We judged three studies to be at high risk of other bias and the remaining four studies to be at unclear risk of other bias. All-cause death: we extracted data from six trials (1517 participants). Cerebrolysin probably results in little to no difference in all-cause death: risk ratio (RR) 0.90, 95% confidence interval (CI) 0.61 to 1.32 (6 trials, 1517 participants, moderate-quality evidence). None of the included trials reported on poor functional outcome defined as death or dependence at the end of the follow-up period or early death (within two weeks of stroke onset), or time to restoration of capacity for work and quality of life. Only one trial clearly reported on the cause of death: cerebral infarct (four in the Cerebrolysin and two in the placebo group), heart failure (two in the Cerebrolysin and one in the placebo group), pulmonary embolism (two in the placebo group), and pneumonia (one in the placebo group). Serious adverse events (SAEs): Cerebrolysin probably results in little to no difference in the total number of people with SAEs (RR 1.15, 95% CI 0.81 to 1.65, 4 RCTs, 1435 participants, moderate-quality evidence). This comprised fatal SAEs (RR 0.90, 95% CI 0.59 to 1.38) and an increase in the total number of people with non-fatal SAEs (RR 2.15, 95% CI 1.01 to 4.55, P = 0.047, 4 trials, 1435 participants, moderate-quality evidence). In the subgroup of dosing schedule 30 mL for 10 days (cumulative dose 300 mL), the increase was more prominent: RR 2.86, 95% CI 1.23 to 6.66, P = 0.01 (2 trials, 1189 participants). Total number of people with adverse events: four trials reported on this outcome. Cerebrolysin may result in little to no difference in the total number of people with adverse events: RR 0.97, 95% CI 0.85 to 1.10, P = 0.90, 4 trials, 1435 participants, low-quality evidence. Non-death attrition: evidence from six trials involving 1517 participants suggests that Cerebrolysin results in little to no difference in non-death attrition, with 96 out of 764 Cerebrolysin-treated participants and 117 out of 753 placebo-treated participants being lost to follow-up for reasons other than death (very low-quality evidence). AUTHORS' CONCLUSIONS: Moderate-quality evidence indicates that Cerebrolysin probably has little or no beneficial effect on preventing all-cause death in acute ischaemic stroke, or on the total number of people with serious adverse events. Moderate-quality evidence also indicates a potential increase in non-fatal serious adverse events with Cerebrolysin use.


Assuntos
Aminoácidos/uso terapêutico , Fármacos Neuroprotetores/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Doença Aguda , Aminoácidos/efeitos adversos , Viés , Isquemia Encefálica/complicações , Causas de Morte , Humanos , Fármacos Neuroprotetores/efeitos adversos , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade
18.
Cochrane Database Syst Rev ; 7: CD013017, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-32608505

RESUMO

BACKGROUND: Intimate partner violence (IPV) against women is prevalent and strongly associated with mental health problems. Women experiencing IPV attend health services frequently for mental health problems. The World Health Organization recommends that women who have experienced IPV and have a mental health diagnosis should receive evidence-based mental health treatments. However, it is not known if psychological therapies work for women in the context of IPV and whether they cause harm. OBJECTIVES: To assess the effectiveness of psychological therapies for women who experience IPV on the primary outcomes of depression, self-efficacy and an indicator of harm (dropouts) at six- to 12-months' follow-up, and on secondary outcomes of other mental health symptoms, anxiety, quality of life, re-exposure to IPV, safety planning and behaviours, use of healthcare and IPV services, and social support. SEARCH METHODS: We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR), CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, and three other databases, to the end of October 2019. We also searched international trials registries to identify unpublished or ongoing trials and handsearched selected journals, reference lists of included trials and grey literature. SELECTION CRITERIA: We included randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs and cross-over trials of psychological therapies with women aged 16 years and older who self-reported recent or lifetime experience of IPV. We included trials if women also experienced co-existing mental health diagnoses or substance abuse issues, or both. Psychological therapies included a wide range of interventions that targeted cognition, motivation and behaviour compared with usual care, no treatment, delayed or minimal interventions. We classified psychological therapies according to Cochrane Common Mental Disorders's psychological therapies list. DATA COLLECTION AND ANALYSIS: Two review authors extracted data and undertook 'Risk of Bias' assessment. Treatment effects were compared between experimental and comparator interventions at short-term (up to six months post-baseline), medium-term (six to under 12 months, primary outcome time point), and long-term follow-up (12 months and above). We used standardised mean difference (SMD) for continuous and odds ratio (OR) for dichotomous outcomes, and used random-effects meta-analysis, due to high heterogeneity across trials. MAIN RESULTS: We included 33 psychological trials involving 5517 women randomly assigned to experimental (2798 women, 51%) and comparator interventions (2719 women, 49%). Psychological therapies included 11 integrative therapies, nine humanistic therapies, six cognitive behavioural therapy, four third-wave cognitive behavioural therapies and three other psychologically-orientated interventions. There were no trials classified as psychodynamic therapies. Most trials were from high-income countries (19 in USA, three in Iran, two each in Australia and Greece, and one trial each in China, India, Kenya, Nigeria, Pakistan, Spain and UK), among women recruited from healthcare, community, shelter or refuge settings, or a combination of any or all of these. Psychological therapies were mostly delivered face-to-face (28 trials), but varied by length of treatment (two to 50 sessions) and staff delivering therapies (social workers, nurses, psychologists, community health workers, family doctors, researchers). The average sample size was 82 women (14 to 479), aged 37 years on average, and 66% were unemployed. Half of the women were married or living with a partner and just over half of the participants had experienced IPV in the last 12 months (17 trials), 6% in the past two years (two trials) and 42% during their lifetime (14 trials). Whilst 20 trials (61%) described reliable low-risk random-sampling strategies, only 12 trials (36%) described reliable procedures to conceal the allocation of participant status. While 19 trials measured women's depression, only four trials measured depression as a continuous outcome at medium-term follow-up. These showed a probable beneficial effect of psychological therapies in reducing depression (SMD -0.24, 95% CI -0.47 to -0.01; four trials, 600 women; moderate-certainty evidence). However, for self-efficacy, there may be no evidence of a difference between groups (SMD -0.12, 95% CI -0.33 to 0.09; one trial with medium-term follow-up data, 346 women; low-certainty evidence). Further, there may be no difference between the number of women who dropped out from the experimental or comparator intervention groups, an indicator of no harm (OR 1.04, 95% CI 0.75 to 1.44; five trials with medium-term follow-up data, 840 women; low-certainty evidence). Although no trials reported adverse events from psychological therapies or participation in the trial, only one trial measured harm outcomes using a validated scale. For secondary outcomes, trials measured anxiety only at short-term follow-up, showing that psychological therapies may reduce anxiety symptoms (SMD -0.96, 95% CI -1.29 to -0.63; four trials, 158 women; low-certainty evidence). However, within medium-term follow-up, low-certainty evidence revealed that there may be no evidence between groups for the outcomes safety planning (SMD 0.04, 95% CI -0.18 to 0.25; one trial, 337 women), post-traumatic stress disorder (SMD -0.24, 95% CI -0.54 to 0.06; four trials, 484 women) or re-exposure to any form of IPV (SMD 0.03, 95% CI -0.14 to 0.2; two trials, 547 women). AUTHORS' CONCLUSIONS: There is evidence that for women who experience IPV, psychological therapies probably reduce depression and may reduce anxiety. However, we are uncertain whether psychological therapies improve other outcomes (self-efficacy, post-traumatic stress disorder, re-exposure to IPV, safety planning) and there are limited data on harm. Thus, while psychological therapies probably improve emotional health, it is unclear if women's ongoing needs for safety, support and holistic healing from complex trauma are addressed by this approach. There is a need for more interventions focused on trauma approaches and more rigorous trials (with consistent outcomes at similar follow-up time points), as we were unable to synthesise much of the research.


Assuntos
Ansiedade/terapia , Depressão/terapia , Violência por Parceiro Íntimo/psicologia , Psicoterapia/métodos , Transtornos de Estresse Pós-Traumáticos/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Ansiedade/diagnóstico , Depressão/diagnóstico , Feminino , Humanos , Pessoa de Meia-Idade , Pacientes Desistentes do Tratamento , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Segurança , Autoeficácia , Transtornos de Estresse Pós-Traumáticos/psicologia , Adulto Jovem
19.
Cochrane Database Syst Rev ; 7: CD009533, 2020 07 03.
Artigo em Inglês | MEDLINE | ID: mdl-32633858

RESUMO

BACKGROUND: Psychosis is an illness characterised by alterations in thoughts and perceptions resulting in delusions and hallucinations. Psychosis is rare in adolescents but can have serious consequences. Antipsychotic medications are the mainstay treatment, and have been shown to be effective. However, there is emerging evidence on psychological interventions such as cognitive remediation therapy, psycho-education, family therapy and group psychotherapy that may be useful for adolescents with psychosis. OBJECTIVES: To assess the effects of various psychological interventions for adolescents with psychosis. SEARCH METHODS: We searched the Cochrane Schizophrenia Group's study-based Register of Trials including clinical trials registries (latest, 8 March 2019). SELECTION CRITERIA: All randomised controlled trials comparing various psychological interventions with treatment-as-usual or other psychological treatments for adolescents with psychosis. For analyses, we included trials meeting our inclusion criteria and reporting useable data. DATA COLLECTION AND ANALYSIS: We independently and reliably screened studies and we assessed risk of bias of the included studies. For dichotomous data, we calculated risk ratios (RRs) and 95% confidence intervals (CIs) on an intention-to-treat basis. For continuous data, we used mean differences (MDs) and the 95% CIs. We used a random-effects model for analyses. We created a 'Summary of findings' table using GRADE. MAIN RESULTS: The current review includes 7 studies (n = 319) assessing a heterogenous group of psychological interventions with variable risk of bias. Adverse events were not reported by any of the studies. None of the studies was sponsored by industry. Below, we summarise the main results from four of six comparisons, and the certainty of these results (based on GRADE). All scale scores are average endpoint scores. Cognitive Remediation Therapy (CRT) + Treatment-as-Usual (TAU) versus TAU Two studies compared adding CRT to participants' TAU with TAU alone. Global state (CGAS, high = good) was reported by one study. There was no clear difference between treatment groups (MD -4.90, 95% CI -11.05 to 1.25; participants = 50; studies = 1, very low-certainty). Mental state (PANSS, high = poor) was reported by one study. Scores were clearly lower in the TAU group (MD 8.30, 95% CI 0.46 to 16.14; participants = 50; studies = 1; very low-certainty). Clearly more participants in the CRT group showed improvement in cognitive functioning (Memory digit span test) compared to numbers showing improvement in the TAU group (1 study, n = 31, RR 0.58, 95% CI 0.37 to 0.89; very low-certainty). For global functioning (VABS, high = good), our analysis of reported scores showed no clear difference between treatment groups (MD 5.90, 95% CI -3.03 to 14.83; participants = 50; studies = 1; very low-certainty). The number of participants leaving the study early from each group was similar (RR 0.93, 95% CI 0.32 to 2.71; participants = 91; studies = 2; low-certainty). Group Psychosocial Therapy (GPT) + TAU versus TAU One study assessed the effects of adding GPT to participants' usual medication. Global state scores (CGAS, high = good) were clearly higher in the GPT group (MD 5.10, 95% CI 1.35 to 8.85; participants = 56; studies = 1; very low-certainty) but there was little or no clear difference between groups for mental state scores (PANSS, high = poor, MD -4.10, 95% CI -8.28 to 0.08; participants = 56; studies = 1, very low-certainty) and no clear difference between groups for numbers of participants leaving the study early (RR 0.43, 95% CI 0.15 to 1.28; participants = 56; studies = 1; very low-certainty). Cognitive Remediation Programme (CRP) + Psychoeducational Treatment Programme (PTP) versus PTP One study assessed the effects of combining two types psychological interventions (CRP + PTP) with PTP alone. Global state scores (GAS, high = good) were not clearly different (MD 1.60, 95% CI -6.48 to 9.68; participants = 25; studies = 1; very low-certainty), as were mental state scores (BPRS total, high = poor, MD -5.40, 95% CI -16.42 to 5.62; participants = 24; studies = 1; very low-certainty), and cognitive functioning scores (SPAN-12, high = good, MD 2.40, 95% CI -2.67 to 7.47; participants = 25; studies = 1; very low-certainty). Psychoeducational (PE) + Multifamily Treatment (MFT) Versus Nonstructured Group Therapy (NSGT, all long-term) One study compared (PE + MFT) with NSGT. Analysis of reported global state scores (CGAS, high = good, MD 3.38, 95% CI -4.87 to 11.63; participants = 49; studies = 1; very low-certainty) and mental state scores (PANSS total, high = poor, MD -8.23, 95% CI -17.51 to 1.05; participants = 49; studies = 1; very low-certainty) showed no clear differences. The number of participants needing hospital admission (RR 0.84, 95% CI 0.36 to 1.96; participants = 49; studies = 1) and the number of participants leaving the study early from each group were also similar (RR 0.52, 95% CI 0.10 to 2.60; participants = 55; studies = 1; low-certainty). AUTHORS' CONCLUSIONS: Most of our estimates of effect for our main outcomes are equivocal. An effect is suggested for only four outcomes in the SOF tables presented. Compared to TAU, CRT may have a positive effect on cognitive functioning, however the same study reports data suggesting TAU may have positive effect on mental state. Another study comparing GPT with TAU reports data suggesting GPT may have a positive effect on global state. However, the estimate of effects for all the main outcomes in our review should be viewed with considerable caution as they are based on data from a small number of studies with variable risk of bias. Further data could change these results and larger and better quality studies are needed before any firm conclusions regarding the effects of psychological interventions for adolescents with psychosis can be made.


Assuntos
Remediação Cognitiva , Terapia Familiar , Psicoterapia de Grupo , Transtornos Psicóticos/terapia , Esquizofrenia/terapia , Adolescente , Viés , Cognição/fisiologia , Terapia Combinada/métodos , Humanos , Memória de Curto Prazo , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Terapia Assistida por Computador , Resultado do Tratamento , Jogos de Vídeo
20.
Niger J Clin Pract ; 23(7): 965-969, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32620726

RESUMO

Background: Dwindling economic resources and reduced manpower in the health sector require efficient use of the available resources. Day of surgery cancellation has far reaching consequences on the patients and the theatre staff involved. Full use of the theatre space should be pursued by every theatre user. Objective: The study aimed to report on the rates and causes of day of surgery cancellation of elective surgical cases in our hospital as a means towards proffering solutions. Materials and Methods: It was a retrospective study of all elective cases that were booked over a 15-month period from January 2016 to March 2017. Cancellation was said to have occurred when the planned surgery did not take place on the proposed day of surgery. Cancellations were categorized into patient-related, surgeon-related, hospital-related and anesthetist-related. Reasons for the cancellations were documented. Data were analyzed using Statistical Package for the Social Sciences (SPSS) software program, version 22. Variables were compared using Chi-square tests. A value of P < 0.05 was considered statistically significant. Results: During the 15-month period, a total of 1296 elective surgeries were booked. Of this, 118 (9.1%) cases were cancelled. Patient-related factor was the most common reason (47.5%) followed by surgeon-related factor (28%). Lack of funds was the most common patient related-reason for cancellation. Majority of the cancelled cases were general surgical cases (36.4%) followed by orthopedics (25.4%) and urology (11%). Seventy percent of the cancelled cases were first and second on the elective list. Conclusion: The cancellation rate in this study is high. The reasons for these cancellations are preventable. To ensure effective use of the theatre, efforts should be made to tackle these reasons.


Assuntos
Procedimentos Cirúrgicos Eletivos/estatística & dados numéricos , Salas Cirúrgicas/estatística & dados numéricos , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Centro Cirúrgico Hospitalar/organização & administração , Adulto , Agendamento de Consultas , Ocupação de Leitos , Feminino , Hospitais de Ensino , Humanos , Masculino , Nigéria , Salas Cirúrgicas/organização & administração , Pacientes Desistentes do Tratamento/psicologia , Estudos Retrospectivos , Recursos Humanos
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