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1.
BMJ Open ; 14(4): e076064, 2024 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-38594182

RESUMO

INTRODUCTION: The paediatric population represents a quarter of the world's population, and like adult patients, they have also suffered immeasurably from the SARS-CoV-2 pandemic. Immunisation is an effective strategy for reducing the number of COVID-19 cases. With the advancements in vaccination for younger age groups, parents or guardians have raised doubts and questions about adverse effects and the number of doses required. Therefore, systematic reviews focusing on this population are needed to consolidate evidence that can help in decision-making and clinical practice. This protocol aims to assess the safety of COVID-19 vaccines in paediatric patients and evaluate the correlation between the number of vaccine doses and side effects. METHODS AND ANALYSIS: We will search the PubMed, ClinicalTrials.gov, Web of Science, Embase, CINAHL, Latin American and Caribbean Health Sciences Literature, Scopus and Cochrane databases for randomised and quasi-randomised clinical trials that list the adverse effects of the COVID-19 vaccine and assess its correlation with the number of doses, without any language restrictions. Two reviewers will select the studies according to the inclusion and exclusion criteria, extract data and asses for risk of bias using the Cochrane risk-of-bias tool. The Review Software Manager (RevMan V.5.4.1) will be used to synthesise the data. We will use the Working Group's Grading of Recommendations Assessment, Development and Evaluations to grade the strength of the evidence of the results. ETHICS AND DISSEMINATION: Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication. PROSPERO REGISTRATION NUMBER: CRD42023390077.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Metanálise como Assunto , SARS-CoV-2 , Revisões Sistemáticas como Assunto , Humanos , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/administração & dosagem , Criança , COVID-19/prevenção & controle , SARS-CoV-2/imunologia , Projetos de Pesquisa
2.
Clinics (Sao Paulo) ; 79: 100330, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38341903

RESUMO

OBJECTIVE: Summarize the evidence on drug therapies for obstructive sleep apnea. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. PubMed, Embase, Scopus, Web of Science, SciELO, LILACS, Scopus, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched on February 17th, 2023. A search strategy retrieved randomized clinical trials comparing the Apnea-Hypopnea Index (AHI) in pharmacotherapies. Studies were selected and data was extracted by two authors independently. The risk of bias was assessed using the Cochrane Risk of Bias tool. RevMan 5.4. was used for data synthesis. RESULTS: 4930 articles were obtained, 68 met inclusion criteria, and 29 studies (involving 11 drugs) were combined in a meta-analysis. Atomoxetine plus oxybutynin vs placebo in AHI mean difference of -7.71 (-10.59, -4.83) [Fixed, 95 % CI, I2 = 50 %, overall effect: Z = 5.25, p < 0.001]. Donepezil vs placebo in AHI mean difference of -8.56 (-15.78, -1.33) [Fixed, 95 % CI, I2 = 21 %, overall effect: Z = 2.32, p = 0.02]. Sodium oxybate vs placebo in AHI mean difference of -5.50 (-9.28, -1.73) [Fixed, 95 % CI, I2 = 32 %, overall effect: Z = 2.86, p = 0.004]. Trazodone vs placebo in AHI mean difference of -12.75 (-21.30, -4.19) [Fixed, 95 % CI, I2 = 0 %, overall effect: Z = 2.92, p = 0.003]. CONCLUSION: The combination of noradrenergic and antimuscarinic drugs shows promising results. Identifying endotypes may be the key to future drug therapies for obstructive sleep apnea. Moreover, studies with longer follow-up assessing the safety and sustained effects of these treatments are needed. PROSPERO REGISTRATION NUMBER: CRD42022362639.


Assuntos
Apneia Obstrutiva do Sono , Apneia Obstrutiva do Sono/tratamento farmacológico , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Cloridrato de Atomoxetina/uso terapêutico , Ácidos Mandélicos/uso terapêutico
3.
BMJ Open ; 14(1): e076456, 2024 01 25.
Artigo em Inglês | MEDLINE | ID: mdl-38272544

RESUMO

INTRODUCTION: Obstructive sleep apnoea (OSA) is a common disorder that can affect the quality of life and increase the risk for psychiatric, neurological and cardiometabolic diseases. Despite the significant burden, it poses on health and well-being, there is a lack of evidence regarding the use of drug therapies in these patients. This work aims to evaluate the efficacy and safety of pharmacological treatment alternatives for patients with OSA. METHODS AND ANALYSIS: Databases, including PubMed, Embase, Web of Science, SciELO, LILACS, Scopus, Cochrane Register of Controlled Trials and ClinicalTrials.gov, will be used for the search. A search strategy was developed to retrieve clinical trials that have evaluated polysomnographic primary outcome (Apnoea-Hypopnoea index) and secondary outcomes (eg, daytime sleepiness, adverse events) of any drug therapy used for OSA. No date or language restrictions will be applied. Two authors will independently select the studies meeting the inclusion criteria by screening the title, abstract and full text. Data will be extracted, and the risk of bias will be evaluated using the Cochrane Risk of Bias Tool. Review Manager V.5.4.1 will be used for data synthesis. The Grading of Recommendation Assessment, Development and Evaluation will be used to assess the strength of the evidence. ETHICS AND DISSEMINATION: As a review of published data, it is not necessary to obtain ethical approval. The findings of this systematic review will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42022362639.


Assuntos
Qualidade de Vida , Apneia Obstrutiva do Sono , Humanos , Metanálise como Assunto , Avaliação de Resultados em Cuidados de Saúde , Apneia Obstrutiva do Sono/tratamento farmacológico , Revisões Sistemáticas como Assunto
4.
J Low Genit Tract Dis ; 28(1): 54-63, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-37934153

RESUMO

OBJECTIVES: We set out to assess the efficacy of physiotherapy for vulvodynia. MATERIALS AND METHODS: PubMed, Embase, Scopus, Web of Science, SciELO, PEDro, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched in February 2023. Two authors selected and extracted the data independently. The risk of bias was assessed using the Cochrane Risk of Bias tool (Rob 2). Because of the high heterogeneity presented between the studies, it was not possible to carry out qualitative analysis. The results were presented narratively. This systematic review was registered with the PROSPERO database. RESULTS: A total of 2,274 articles were retrieved. Seven studies met the criteria and were included in a systematic review, which included a total of 477 patients. The interventions included were electromyography biofeedback ( n = 2), transcutaneous electrical nerve stimulation ( n = 1), transcranial direct current stimulation ( n = 1), low-intensity shockwave ( n = 1), physiotherapy treatment ( n = 1), and pelvic floor exercise with behavioral modification ( n = 1). All studies evaluated pain reduction, 5 evaluated sexual function, and 2 evaluated quality of life. All interventions were effective for the main outcomes; only the transcranial direct current stimulation intervention showed no significant difference when compared with the placebo or sham group. Three studies presented a high risk of bias due to the lack of blinding. CONCLUSIONS: The studied interventions (electromyography biofeedback, transcutaneous electrical nerve stimulation, shockwave, physiotherapy, and pelvic floor exercise) seem to improve pain, sexual function, and quality of life. However, the heterogeneity of the studies prevented meta-analysis. In addition, well-designed trials are needed to improve the certainty of this evidence.


Assuntos
Estimulação Transcraniana por Corrente Contínua , Vulvodinia , Feminino , Humanos , Vulvodinia/terapia , Qualidade de Vida , Modalidades de Fisioterapia , Dor
5.
Clinics ; 79: 100330, 2024. tab, graf
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1534243

RESUMO

Abstract Objective Summarize the evidence on drug therapies for obstructive sleep apnea. Methods The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. PubMed, Embase, Scopus, Web of Science, SciELO, LILACS, Scopus, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched on February 17th, 2023. A search strategy retrieved randomized clinical trials comparing the Apnea-Hypopnea Index (AHI) in pharmacotherapies. Studies were selected and data was extracted by two authors independently. The risk of bias was assessed using the Cochrane Risk of Bias tool. RevMan 5.4. was used for data synthesis. Results 4930 articles were obtained, 68 met inclusion criteria, and 29 studies (involving 11 drugs) were combined in a meta-analysis. Atomoxetine plus oxybutynin vs placebo in AHI mean difference of -7.71 (-10.59, -4.83) [Fixed, 95 % CI, I2 = 50 %, overall effect: Z = 5.25, p < 0.001]. Donepezil vs placebo in AHI mean difference of -8.56 (-15.78, -1.33) [Fixed, 95 % CI, I2 = 21 %, overall effect: Z = 2.32, p = 0.02]. Sodium oxybate vs placebo in AHI mean difference of -5.50 (-9.28, -1.73) [Fixed, 95 % CI, I2 = 32 %, overall effect: Z = 2.86, p = 0.004]. Trazodone vs placebo in AHI mean difference of -12.75 (-21.30, -4.19) [Fixed, 95 % CI, I2 = 0 %, overall effect: Z = 2.92, p = 0.003]. Conclusion The combination of noradrenergic and antimuscarinic drugs shows promising results. Identifying endotypes may be the key to future drug therapies for obstructive sleep apnea. Moreover, studies with longer follow-up assessing the safety and sustained effects of these treatments are needed. PROSPERO registration number CRD42022362639.

6.
Rev. bras. ginecol. obstet ; 46: x-xx, 2024. tab, graf
Artigo em Inglês | LILACS | ID: biblio-1565342

RESUMO

Abstract Objective: This meta-analysis of randomized controlled trials (RCTs) aimed to update evidence on the effectiveness and safety of laser therapy for treating genitourinary syndrome of menopause (GSM). Data sources: Manuscripts published until May 2023 were systematically searched in PubMed; Embase; Scopus; Web of Science; CENTRAL; CINAHL; and clinical trial databases (www.trialscentral.org, www.controlled-trials.com, and clinicaltrials.gov), with no language and year of publication restriction. Studies selection: RCTs with women diagnosed with GSM, and the intervention was vaginal laser therapy (CO2-laser or Er: YAG-laser) comparing with placebo (sham therapy), no treatment or vaginal estrogen therapy. Data collection: Two authors evaluated the publications for inclusion based on the title and abstract, followed by reviewing the relevant full-text articles. Disagreements during the review process were addressed by consensus, with the involvement of a third author. Data synthesis: Twelve RCTs, representing a total of 5147 participants, were included in this review. Vaginal health index (VHI) significantly improved in the carbon dioxide laser (CO2-laser) therapy group (MD=2.21; 95% CI=1.25 to 3.16), while dyspareunia (MD=−0.85; 95% CI=−1.59 to −0.10), dryness (MD=−0.62; 95% CI=−1.12 to −0.12) and burning (MD= −0.64; 95% CI=−1.28 to −0.01) decreased. No serious adverse effects were reported. Conclusion: CO2-laser increases VHI score and decreases dyspareunia, dryness and burning, especially when compared to sham-laser. However, the certainty of the evidence is low, thus preventing the recommendation of laser therapy for GSM management.


Assuntos
Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Menopausa , Pós-Menopausa , Doenças Urogenitais Femininas , Terapia a Laser
7.
Int J Gynaecol Obstet ; 166(1): 163-172, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38102987

RESUMO

BACKGROUND: Energy-based devices (laser and radiofrequency) have been used to treat genitourinary syndrome of menopause (GSM). OBJECTIVES: To evaluate the efficacy and safety of physical energy use in managing GSM symptoms. SEARCH STRATEGY: Five databases were searched from inception to December 2022. Language restrictions were not imposed. SELECTION CRITERIA: We included all Cochrane and non-Cochrane systematic reviews with or without meta-analyses that described postmenopausal women with symptoms of GSM treated with physical energy. DATA COLLECTION AND ANALYSIS: We performed a network meta-analysis using frequentist methods to calculate standardized mean differences (SMDs) and their corresponding 95% confidence intervals (CIs). Methodological and reporting quality were assessed using the Assessment of Multiple Systematic Reviews (AMSTAR 2). MAIN RESULTS: Nine reviews were included in the overview, six of which were meta-analyses. Four randomized controlled trials, representing 218 participants and nine different study arms, met the criteria for inclusion in our component network meta-analysis. Confidence in review findings was low in six reviews and critically low in three. Our network meta-analysis results showed that premarin (SMD 2.60, 95% CI 7.76-3.43), conjugated estrogens (SMD 2.13, 95% CI 1.34-2.91), carbon dioxide laser (SMD 1.71, 95% CI 1.10-2.31), promestriene (SMD 1.41, 95% CI 0.59-2.24), and vaginal lubricant (SMD 1.37, 95% CI 0.54-2.20) were more effective than sham for reducing sexual dysfunction, with a consequent increase in Female Sexual Function Index (FSFI). Two studies showed a high risk of bias, owing to a lack of blinding. CONCLUSION: Several gaps in the use of physical energy for managing GSM still need to be addressed. The small number of blind clinical trials made the results fragile.


Assuntos
Doenças Urogenitais Femininas , Menopausa , Metanálise em Rede , Humanos , Feminino , Doenças Urogenitais Femininas/terapia , Síndrome , Terapia por Radiofrequência/métodos , Terapia a Laser/métodos
8.
Integr Cancer Ther ; 22: 15347354231220608, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38140826

RESUMO

OBJECTIVE: evaluate the efficacy of Zingiber Officinale in the management of nausea and vomiting induced by treatment with cisplatin associated with radiotherapy in patients with uterine cervical neoplasms. METHODS: a triple-blind, randomized, placebo-controlled trial. Interventions: Comparing the effects of ginger with institutional antiemetic therapy (ondansetron with dexamethasone). Patients with cervical cancer who started treatment with cisplatin with an indication of 40 mg/m² associated with radiotherapy, aged over 18 years, and with the ability to tolerate swallowing a capsule were recruited and equally allocated (1:1:1) into 3 groups of 16 patients each (the ginger capsules 250 mg group, ginger capsules 500 mg group, and placebo group). Nausea and vomiting were measured on baseline, 7 days after the first dose of medication and every seven consecutive days during a treatment break. RESULTS: The 250 mg ginger group had an 8.0% greater chance of experiencing nausea within 24 h after the chemotherapy infusion than the placebo group, although there is no statistical significance (P = .92986). The 500 mg ginger group showed a 63.9% reduction in nausea under the same conditions (P = .40460). No change was detected in the occurrence of nausea episodes during the 6 weeks (P = .8664) or between the groups (P = .2817). No change was detected in acute or late vomiting during the 6 weeks (P = .3510) or between the groups (P = .8500 and P = .5389, respectively). CONCLUSION: Ginger supplementation does not reduce the intensity of acute and late nausea and vomiting. REBEC (RBR-47yx6p9).


Assuntos
Neoplasias do Colo do Útero , Zingiber officinale , Feminino , Humanos , Adulto , Pessoa de Meia-Idade , Cisplatino/efeitos adversos , Método Duplo-Cego , Vômito/induzido quimicamente , Vômito/tratamento farmacológico , Náusea/induzido quimicamente , Náusea/tratamento farmacológico
10.
BMJ Open ; 13(11): e075841, 2023 11 10.
Artigo em Inglês | MEDLINE | ID: mdl-37949628

RESUMO

INTRODUCTION: Breast cancer survivors (BCSs) experience more severe symptoms of genitourinary syndrome of menopause (GSM) than healthy postmenopausal women. As hormonal therapy with oestrogen should be avoided in BCSs, finding an effective and safe therapy to address vaginal symptoms and sexual dysfunction is urgently needed. Physical methods may be promising alternatives for the specificities of this group of women. This review aims to evaluate the efficacy and safety of physical methods (laser and radiofrequency) for treating GSM in BCSs. METHODS AND ANALYSIS: The PubMed, Embase, Web of Science, SciELO, LILACS, Scopus, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov databases will be searched. A search strategy was developed to retrieve clinical trials that evaluate the efficacy and safety of any physical method (laser or radiofrequency) used for GSM in BCSs. No date or language restrictions will be imposed. Two authors will independently select studies by title, abstract and full text to meet the inclusion criteria. Data will be extracted, and the risk of bias will be evaluated using the Cochrane risk-of-bias tool (RoB 2). Review Manager 5.4.1 will be used for data synthesis. The Grading of Recommendations, Assessment, Development and Evaluation will be used to assess the strength of the evidence. ETHICS AND DISSEMINATION: This study reviews the published data; thus, obtaining ethical approval is unnecessary. The findings of this systematic review will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42023387680.


Assuntos
Neoplasias da Mama , Sobreviventes de Câncer , Doenças dos Genitais Femininos , Feminino , Humanos , Neoplasias da Mama/terapia , Revisões Sistemáticas como Assunto , Metanálise como Assunto , Menopausa , Lasers , Literatura de Revisão como Assunto
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