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1.
Heart Lung ; 67: 183-190, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38848628

RESUMO

BACKGROUND: Obstructive sleep apnoea (OSA) is a disabling health condition, and there is no disease-specific patient-reported outcome instrument to assess individuals with OSA. OBJECTIVES: To evaluate the psychometric properties of the Brazilian version of the World Health Organization Disability Assessment Schedule (WHODAS 2.0) in individuals with OSA. METHODS: One hundred individuals with OSA responded to the WHODAS 2.0 version of 36 items, the Epworth Sleepiness Scale (ESS), the Pittsburgh Sleep Quality Index (PSQI), and the 12-item health survey (SF-12). Internal consistency, convergent and discriminative validity, and responsiveness to continuous positive airway pressure (CPAP) were the psychometric properties tested. RESULTS: Cronbach's α values indicate good internal consistency (0.91 - 0.73), except for the self-care domain (α = 0.52). Convergent validity indicated an excellent correlation (r = -0.80) between the domains of functioning and quality of life. Discriminative validity showed no association between OSA severity and functioning (p = 0.90). The responsiveness to CPAP treatment showed a large effect size (r = 0.82; p < 0.05) CONCLUSIONS: The WHODAS 2.0 instrument is valid, reliable, and responsive for assessing individuals with OSA.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas , Avaliação da Deficiência , Psicometria , Qualidade de Vida , Apneia Obstrutiva do Sono , Organização Mundial da Saúde , Humanos , Apneia Obstrutiva do Sono/diagnóstico , Apneia Obstrutiva do Sono/terapia , Masculino , Feminino , Brasil , Reprodutibilidade dos Testes , Pessoa de Meia-Idade , Psicometria/instrumentação , Psicometria/métodos , Pressão Positiva Contínua nas Vias Aéreas/métodos , Qualidade de Vida/psicologia , Inquéritos e Questionários , Adulto , Índice de Gravidade de Doença , Idoso , Polissonografia/métodos
2.
Front Endocrinol (Lausanne) ; 15: 1326212, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38711983

RESUMO

Background: Parkinson's disease (PD) is the second most common neurodegenerative illness and has the highest increase rate in recent years. There is growing evidence to suggest that PD is linked to higher osteoporosis rates and risk of fractures. Objective: This study aims to estimate the prevalence and factors associated with osteoporosis as defined by the National Osteoporosis Foundation (NOF) and World Health Organization in patients with mild to moderate PD. Methods: We performed a cross-sectional study at a tertiary public hospital in Fortaleza, Brazil, dating from May 2021 until April 2022. The study sample was comprised of patients with mild to moderate PD who were at least 40 years old and who had the ability to walk and stand unassisted. Bone Mineral Density (BMD) of both the hip (neck of the femur) and the lumbar spine were obtained via properly calibrated Dual Energy X-ray Absorptiometry (DXA) scanning. The FRAX (Fracture Risk Assessment Tool) score was used to determine a person's 10-year risk of major osteoporotic fracture. The Revised European Working Group on Sarcopenia in Older People (EWGSOP 2) was used as a basis to confirm a sarcopenia diagnosis with the following parameters: low muscle strength gauged by handgrip strength and low muscle quantity by DXA. Physical performance was carefully evaluated by using the Short Physical Performance Battery test. Osteoporosis and osteopenia were diagnosed following the NOF guidelines and WHO recommendations. Results: We evaluated 107 patients in total, of whom 45 (42%) were women. The group's mean age was 68 ± 9 years, and the mean disease time span was 9.9 ± 6.0 years and mean motor UPDRS was 43 ± 15. We found that 42.1% and 34.6% of the sample had osteopenia and osteoporosis following NOF criteria, respectively, and 43% and 33.6% following the WHO recommendations. Lower lean appendicular mass was associated to osteopenia and osteoporosis in multinomial logistic regression analysis in both diagnostic criteria. Conclusion: Our findings provide additional evidence for the protective role of lean mass against osteoporosis in patients with PD.


Assuntos
Densidade Óssea , Osteoporose , Doença de Parkinson , Centros de Atenção Terciária , Humanos , Estudos Transversais , Feminino , Masculino , Brasil/epidemiologia , Doença de Parkinson/epidemiologia , Doença de Parkinson/fisiopatologia , Doença de Parkinson/complicações , Osteoporose/epidemiologia , Idoso , Pessoa de Meia-Idade , Absorciometria de Fóton , Prevalência , Composição Corporal , Índice de Massa Corporal , Fatores de Risco , Idoso de 80 Anos ou mais
3.
J. Health Biol. Sci. (Online) ; 12(1): 1-5, jan.-dez. 2024. tab, ilus
Artigo em Inglês | LILACS | ID: biblio-1530657

RESUMO

Aim: this study aimed to evaluate the effects of surgical treatment for endometriosis on the metabolic profile of women diagnosed with deep endometriosis. Methods: we conducted a prospective observational study with a sample of 30 women in the menacme diagnosed with deep endometriosis who underwent videolaparoscopic surgery in a reference center in Brazil between October 2020 and December 2021. A total of 30 women performed clinical and laboratory tests regarding their metabolic profile on two occasions, during preoperative tests and six months after video-laparoscopy. Results: patients had lower average levels of Total Cholesterol (TC), Low-Density Cholesterol (LDL-c), Triglycerides (TGC), and Fasting Glycemia (FG) after the surgical procedure. The average TC level was 8.2% lower after surgery, LDL-c was 12.8% lower, TGC was 10.9% lower, and FG was 7.3% lower. The results showed a statistically significant difference for all these parameters (p < 0.001). Conclusions: video-laparoscopy was associated with a favorable lipid profile compared to the preoperative lipid profile, with a significant improvement in the average levels of LDL-c, HDL-c, TC, TGC, and FG. Long-term follow-up studies are needed to determine whether surgical treatment for endometriosis can improve the metabolic parameters of women with endometriosis and favor a lower predisposition to atherogenesis.


Objetivo: Aeste estudo teve como objetivo avaliar os efeitos do tratamento cirúrgico da endometriose no perfil metabólico de mulheres com diagnóstico de endometriose profunda. Métodos: foi realizado um estudo observacional prospectivo com uma amostra de 30 mulheres na menacme, com diagnóstico de endometriose profunda, que foram submetidas à videolaparoscopia em um centro de referência no Brasil, entre outubro de 2020 e dezembro de 2021. As mulheres realizaram exames clínicos e laboratoriais quanto ao seu perfil metabólico em duas ocasiões, durante exames pré-operatórios e seis meses após a videolaparoscopia. Resultados: as pacientes apresentaram níveis médios mais baixos de Colesterol Total (CT), Colesterol de Baixa Densidade (LDL-c), Triglicerídeos (TGC) e Glicemia de Jejum (GJ) após o procedimento cirúrgico. O nível médio de CT foi 8,2% menor após a cirurgia, o LDL-c foi 12,8% menor, o TGC foi 10,9% menor e a GJ foi 7,3% menor. Os resultados mostraram diferença estatisticamente significativa para todos esses parâmetros (p < 0,001). Conclusões: a videolaparoscopia foi associada a um perfil lipídico favorável em comparação ao perfil lipídico pré-operatório, com melhora significativa nos níveis médios de LDL-c, HDL-c, CT, TGC e GJ. Estudos de acompanhamento a longo prazo são necessários para determinar se o tratamento cirúrgico da endometriose pode melhorar os parâmetros metabólicos de mulheres com endometriose e favorecer uma menor predisposição à aterogênese.


Assuntos
Humanos , Feminino , Endometriose , Comorbidade , Painel Metabólico Abrangente
4.
Sleep Breath ; 28(3): 1187-1195, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38252255

RESUMO

PURPOSE: To investigate a possible association between the risk of obstructive sleep apnoea (OSA) and disability in individuals with cardiovascular or cerebrovascular diseases. METHODS: Cross-sectional study was conducted with 373 individuals (313 with cardiovascular or cerebrovascular diseases and 60 healthy). Disability was assessed by the 12-item World Health Organization Disability Assessment Schedule (WHODAS), and the risk of OSA was assessed by STOP-BANG. Anxiety and depression symptoms, daytime sleepiness, and cognition were assessed by the Hospital Anxiety and Depression Scale (HADS), Epworth Sleepiness Scale (ESS), and Mini Mental State Examination (MMSE). RESULTS: Greater disability was found in individuals with intermediate or high risk of OSA, considering healthy individuals (p=0.03), or individuals diagnosed with arrhythmia (p<0.01) or coronary artery disease (p=0.04). A high risk of OSA and higher WHODAS scores was significant among women as well as between OSA risk categories (p<0.01). Cognitive deficit and level of education also showed differences between OSA risk categories. Age, depression, and sleepiness were also associated with the subjects' disability (p<0.01). Gamma regression model showed higher WHODAS scores in female, in those with intermediate and high risk of OSA, and in those with depressive symptoms and cognitive deficit. Age also showed a correlation with higher WHODAS scores. The presence of all investigated cardio and cerebrovascular diseases showed an increase in the WHODAS score, implying a greater disability compared to healthy individuals. CONCLUSION: Moderate and high risk of OSA is associated with disability, as well as gender, age, depressive symptoms, cognitive deficit, and cardiovascular diseases.


Assuntos
Doenças Cardiovasculares , Transtornos Cerebrovasculares , Apneia Obstrutiva do Sono , Humanos , Apneia Obstrutiva do Sono/epidemiologia , Apneia Obstrutiva do Sono/diagnóstico , Feminino , Masculino , Pessoa de Meia-Idade , Estudos Transversais , Doenças Cardiovasculares/epidemiologia , Transtornos Cerebrovasculares/epidemiologia , Idoso , Avaliação da Deficiência , Adulto , Fatores de Risco , Comorbidade
5.
Rev. bras. ginecol. obstet ; 46: x-xx, 2024. tab
Artigo em Inglês | LILACS | ID: biblio-1565341

RESUMO

Abstract Objective To evaluate the effects of surgical treatment of deep endometriosis on the metabolic profile, quality of life and psychological aspects. Methods Prospective observational study, carried out with women of reproductive age diagnosed with deep endometriosis, treated in a specialized outpatient clinic, from October/2020 to September/2022, at a University Hospital in Fortaleza - Brazil. Standardized questionnaires were applied to collect data on quality of life and mental health, in addition to laboratory tests to evaluate dyslipidemia and dysglycemia, at two moments, preoperatively and six months after surgery. The results were presented using tables, averages and percentages. Results Thirty women with an average age of 38.5 years were evaluated. Seven quality of life domains showed improved scores: pain, control and impotence, well-being, social support, self-image, work life and sexual relations after surgery (ES ≥ 0.80). There was an improvement in mental health status with a significant reduction in anxiety and depression postoperatively. With the metabolic profile, all average levels were lower after surgery: total cholesterol 8.2% lower, LDL 12.8% lower, triglycerides 10.9% lower, and fasting blood glucose 7.3% lower (p < 0.001). Conclusion Surgical treatment of deep endometriosis improved the quality of life and psychological aspects of patients. The lipid profile of patients after laparoscopy was favorable when compared to the preoperative lipid profile.


Assuntos
Humanos , Feminino , Ansiedade , Qualidade de Vida , Inquéritos e Questionários , Laparoscopia , Dor Pélvica , Depressão , Endometriose , Inflamação , Lipídeos
6.
Acta Cir Bras ; 38: e386423, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38055399

RESUMO

PURPOSE: This study aimed to assess the necessity of routine intraoperative cell salvage in liver transplantations. METHODS: A total of 327 liver transplants performed between 2014 and 2016 was included in the analysis. Patient data, including pre-transplant examinations, intraoperative red blood cell transfusions, and procedural information, were collected. RESULTS: The median age of the patients was 54 years old, with 67% (219) being male. The most prevalent ABO blood type was O, accounting for 48% (155) of cases. The leading causes of liver disease were hepatitis C (113 cases, 34.6%) and alcohol-related liver disease (97 cases, 29.7%). Out of the 327 liver transplants, allogeneic red blood cell transfusions were administered in 110 cases (34%) with a median of two units of red blood cells per case. Cell salvage was employed in 237 transplants (73%), and successful blood recovery was achieved in 221 cases (93%). Among the group that recovered more than 200 mL of blood, the median volume of recovered blood was 417 mL, with no transfusion of allogeneic blood required. A total of 90 transplants was performed without utilizing cell salvage, and, among these cases, 19 required blood transfusions, with a median of zero units transfused. CONCLUSIONS: This study suggests that routine cell salvage is unnecessary for all liver transplantations. The most suitable indication for its use is in patients presenting with portal vein thrombosis and abnormal creatinine levels.


Assuntos
Hepatopatias , Transplante de Fígado , Humanos , Masculino , Pessoa de Meia-Idade , Feminino , Transfusão de Sangue Autóloga , Transplante de Fígado/efeitos adversos , Transfusão de Sangue , Período Intraoperatório , Hepatopatias/etiologia , Estudos Retrospectivos
7.
Front Med (Lausanne) ; 10: 1215916, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37928473

RESUMO

Background: In 2019, a highly pathogenic coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) surfaced and resulted in the outbreak of coronavirus disease 2019 (COVID-19). With the aim of finding effective drugs to fight against the disease, several trials have been conducted since COVID-19 can only be considered a treatable disease, from a clinical point of view, after the availability of specific and effective antivirals. AZVUDINE (FNC), initially developed for treating HIV, is a potential treatment for COVID-19 as it has the capability to lower the patient's viral load and promote recovery. Methods: Volunteers infected with SARS-CoV-2 confirmed by reverse transcription polymerase chain reaction (RT-PCR), with good kidney and liver function, who were not using other antivirals or monoclonal antibodies were eligible. Samples from patients were assessed for viral load every 48 h during treatment using reverse transcription quantitative polymerase chain reaction (RT-qPCR) and droplet digital polymerase chain reaction (ddPCR). Results: The study's primary outcome measure was the percentage of participants showing an improvement in clinical scores, while the secondary outcome measure was the percentage of participants with a clinical outcome of cure. These measures were used to assess the safety and efficacy of FNC for treating COVID-19. In the analysis of sociodemographic variables, no significant differences were detected between patients in the FNC and the placebo group for race, age group, or sex. The results showed a potential benefit to participants who received FNC during the study, as observed in the shorter hospital stay, shorter negative conversion time of SARS-CoV-2, and a significant reduction in viral load. Furthermore, the reduction in fever and chills were significant at D1, D2, and D3. In this study, a total of 112 adverse events cases were noted, with 105 cases being categorized as non-serious and only 7 cases as serious adverse events. Conclusion: The pandemic is not being effectively controlled and is causing multiple waves of infection that require extensive medical resources. However, FNC has demonstrated potential to reduce the treatment duration of moderate COVID-19 cases, thereby saving significant medical resources. This makes FNC a promising candidate for COVID-19 treatment.Clinical trial registration: [clinicaltrials.gov], identifier [NCT04668235].

8.
Arq. neuropsiquiatr ; 81(11): 949-955, Nov. 2023. tab, graf
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1527891

RESUMO

Abstract Background Detailed information about the electromyography practice in Brazil is largely unavailable. Objective To evaluate where and how electromyography is performed in Brazil, as well as regional disparities and the professional and academic credentials of electromyographers. Methods We conducted an internet-based survey of active Brazilian electromyographers. The websites of health insurance companies, professional academies, medical cooperatives, online search engines, and social networks in each Brazilian state were screened and we evaluated the credentials of each electromyographer listed in the Brazilian Federal Medical Board (BFMB) registration website and their online curricula vitae in the Brazilian National Council for Scientific and Technological Development (Conselho Nacional de Desenvolvimento Científico e Tecnológico, CNPq, in Portuguese). We also evaluated the same parameters in a control group of non-electromyographer neurologists randomly matched by geographical distribution and gender. Results We found 469 electromyographers (384 neurologists and 85 non-neurologists), with a male predominance. In total, 81.9% were BFMB-certified neurologists, 49.9%, BFMB-certified clinical neurophysiologists, and 10.4%, BFMB-certified physiatrists. Among the non-neurologists, 48.2% were physiatrists. Most electromyographers practiced in states on the Southern and Southeastern regions of Brazil. When adjusted by population, the Federal District and the states of Mato Grosso do Sul and Goiás presented the highest of eletromyographers density. Electromyographers were not more likely to have current/past academic affiliations. Conclusion In Brazil, electromyography is performed predominantly by neurologists, and half of them are BFMB-certified clinical neurophysiologists. The present study highlights regional disparities and may guide government-based initiatives, for instance, to improve the diagnosis of leprosy and the management of neuromuscular disorders within the Brazilian territory.


Resumo Antecedentes Informações detalhadas sobre a prática de eletromiografia no Brasil são em grande parte indisponíveis. Objetivo Avaliar onde e como a eletromiografia é realizada no Brasil, as disparidades regionais, e as credenciais profissionais e acadêmicas dos eletromiografistas. Métodos Realizamos uma enquete via internet de eletromiografistas brasileiros ativos. Foram rastreados sites de operadoras de planos de saúde, academias profissionais médicas, cooperativas médicas, ferramentas de busca online e redes sociais em cada estado brasileiro. Em seguida, avaliamos as credenciais de cada eletromiografista listado no site de registro do Conselho Federal de Medicina (CFM) e seus curricula vitae online no Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq). Também avaliamos os mesmos parâmetros em um grupo controle de neurologistas não eletromiografistas pareados aleatoriamente por distribuição geográfica e gênero. Resultados Encontramos 469 eletromiografistas (384 neurologistas e 85 não neurologistas), com predominância do sexo masculino. Ao todo, 81,9% eram neurologistas com certificação confirmada pelo site do CFM, 49,9%, neurofisiologistas clínicos com certificação confirmada pelo site do CFM, e 10,4%, fisiatras com certificação confirmada pelo mesmo site. Entre os não neurologistas, 48,2% eram fisiatras. A maioria dos eletromiografistas atuava nos estados do Sul e do Sudeste. Quando ajustados pela população, o Distrito Federal e os estados de Mato Grosso do Sul e Goiás apresentaram a maior densidade de eletromiografistas. Os eletromiografistas não eram mais propensos a ter vínculos acadêmicos atuais/passados. Conclusão No Brasil, a eletromiografia é realizada predominantemente por neurologistas, e metade deles são neurofisiologistas clínicos com certificação confirmada pelo site do CFM. Este estudo destacou as disparidades regionais, e pode orientar ações governamentais para, por exemplo, melhorar o diagnóstico da hanseníase e o manejo das doenças neuromusculares no território brasileiro.

9.
J Parkinsons Dis ; 13(6): 947-959, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37458047

RESUMO

BACKGROUND: Parkinson's disease (PD) and sarcopenia share similar pathophysiological mechanisms. OBJECTIVE: Estimate the prevalence of sarcopenia in PD patients and describe clinical and demographic features associated with sarcopenia. METHODS: A cross-sectional study was carried out at a tertiary public hospital in Brazil. A modified HY scale of stage 1 to 3, being at least 40 years old and having the ability to stand and walk unassisted were required for eligibility. We evaluated physical performance and muscle mass using DEXA. RESULTS: The study population comprised 124 patients, of which 53 (42.7%) were women. The mean age and mean disease duration were 65.8±10.5 and 10.1±5.8 years, respectively. The mean handgrip strength of 20.4±6.9 in woman and 34.6±8.4 kg in men. Moreover, 50.8% patients had positive SARC-F, 20% patients had probable sarcopenia, 9.6% confirmed sarcopenia, and 16.8% patients showed low muscle mass quantity measured by DEXA. Lower Levodopa Equivalent Dosage (LED) and calf circumference (CC) were independently associated with confirmed sarcopenia. LLED, higher MDS-UPDRS Part III, and lower MMSE scores were independently associated with probable sarcopenia. The CC demonstrated accuracy to identify PD patients with confirmed sarcopenia with a cut-off of <31 cm in women and <34 cm in men. CONCLUSION: We found low prevalence of confirmed sarcopenia among PD patients. We propose that healthcare providers introduce measuring CC, which is a quick and inexpensive method to assess for sarcopenia in PD patients.


Assuntos
Doença de Parkinson , Sarcopenia , Masculino , Humanos , Feminino , Adulto , Sarcopenia/diagnóstico , Sarcopenia/epidemiologia , Sarcopenia/etiologia , Força da Mão/fisiologia , Doença de Parkinson/complicações , Doença de Parkinson/epidemiologia , Estudos Transversais , Levodopa , Inquéritos e Questionários
10.
Complement Med Res ; 30(4): 332-339, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37231828

RESUMO

BACKGROUND: N-of-1 studies allow the formal assessment of a patient's treatment. A single participant receives different interventions the same number of times in a crossover, double-blind, randomized design. Using this methodology, we will investigate the effectiveness and safety of a standardized homeopathy protocol in treating 10 cases of major depression. METHODS: The method is described below: Design: crossover double-blind placebo-controlled randomized N-of-1 studies, with at most 28 weeks of duration per participant. PARTICIPANTS: women and men at age over 18 years with a diagnosis of a major depressive episode given by a psychiatrist, who have presented a therapeutic response, i.e., a reduction ≥50% of the baseline depressive symptoms, self-assessed by the Beck Depression Inventory - Second Edition (BDI-II), and sustained for at least 4 weeks during an open homeopathic treatment following the protocol of the sixth edition of the Organon, with or without concomitant use of psychotropic drugs. INTERVENTIONS: individualized homeopathy following the same protocol, one globule of the fifty-millesimal potency diluted in 20 mL of 30% alcohol; placebo - 20 mL of 30% alcohol, in the same posology as homeopathy. Crossover study: the participant will go through three consecutive treatment blocks, with two random and masked treatment periods (A or B), corresponding to homeopathy or placebo. Treatment periods will have 2, 4, and 8 weeks in the first, second, and third blocks, respectively. A clinically significant worsening (characterized by an augmentation in BDI-II inclusion score ≥30%) will result in the termination of study participation and resumption of the open treatment. PRIMARY MEASURE: progression of the depressive symptoms, self-assessed by the participant using the BDI-II scale at weeks 0, 2, 4, 8, 12, 16, 20, 24, 28 and analyzed throughout the study concerning homeopathy and placebo partitions. Secondary measures: score of the Clinical Global Impression Scale; mental and physical health scores assessed by the 12-Item Short-Form Health Survey; participant's blind preference for treatment A or B at each block; clinical worsening; and adverse events. DATA ANALYSIS: the participant, assistant physician, evaluator, and statistician will remain blinded for the study treatments until the completion of data analysis of each study. We will follow a 10-step procedure for analyzing N-of-1 observational data of each participant and conduct a meta-analysis of the combined results. DISCUSSION: We understand that each N-de-1 study will be a chapter with its teachings in a book of ten, allowing a broader view of the effectiveness of the homeopathy protocol of the sixth edition of the Organon in treating depression.HintergrundEinzelpatienten- oder "n = 1"-Studien ermöglichen die formelle Beurteilung der Behandlung eines Patienten. Bei einem einzigen Teilnehmer werden verschiedene Maßnahmen in gleicher Zahl in einem doppelblinden, randomisierten Crossover-Design angewendet. Mit dieser Methode untersuchen wir die Wirksamkeit und Sicherheit eines standardisierten Homöopathie-Protokolls zur Behandlung von Major Depression in zehn Fällen.MethodenAufbau der Studie: Doppelblinde, placebokontrollierte, randomisierte Einzelpatienten- oder "n = 1"-Studie von maximal 28 Wochen Dauer pro Teilnehmer. Teilnehmer: Frauen und Männer ab 18 Jahren mit durch einen Psychiater diagnostizierter Episode einer Major Depression und mit mindestens vier Wochen lang anhaltendem therapeutischem Ansprechen (in Form einer Reduktion der depressiven Symptome um ≥50% gegenüber Baseline laut Selbstbeurteilung mit dem Beck Depression Inventar, zweite Ausgabe [BDI-II]) unter einer offenen homöopathischen Behandlung gemäß dem Protokoll der sechsten Auflage des Organon, mit oder ohne gleichzeitige Anwendung von Psychopharmaka. Interventionen: Individualisierte Homöopathie gemäß demselben Protokoll, ein Globulus der Quinquaginta-Millesimal-Potenz, verdünnt in 20 mL 30%igem Alkohol; Placebo in Form von 20 mL 30%igem Alkohol, nach demselben Dosierungsschema wie die Homöopathie. Crossover-Studie: Der Teilnehmer durchläuft in zwei randomisierten und maskierten Behandlungszeiträumen (A oder B), die Homöopathie oder Placebo enstprechen, je drei aufeinanderfolgende Behandlungsblöcke. Innerhalb der Behandlungszeiträume umfassen der erste, zweite und dritte Block je zwei, vier beziehungsweise acht Wochen. Eine klinisch bedeutsame Verschlechterung (gekennzeichnet durch einen Anstieg des BDI-II-Scores um ≥30% gegenüber der Aufnahme) führt zum Abbruch der Studienteilnahme und zur Wiederaufnahme der offenen Behandlung. Primäre Messgröße: Verlauf der depressiven Symptome laut Selbstbeurteilung des Teilnehmers mit der BDI-II-Skala in Woche 0, 2, 4, 8, 12, 16, 20, 24, 28 und Auswertung im Verlauf der Studie nach Homöopathie-und Placebo-Abschnitten. Sekundäre Messgrößen: Score auf der Clinical Global Impression Scale; Scores für psychische und physische Gesundheit laut 12-Item Short-Form Health Survey; verblindete Teilnehmerpräferenz für Behandlung A oder B in jedem Block; klinische Ver-schlechterung und unerwünschte Ereignisse. Datenauswertung: Der Teilnehmer, behandelnde Arzt, Auswertende und Statistiker bleiben im Hinblick auf die Stu-dienbehandlungen verblindet, bis die Datenauswertung jeder Studie abgeschlossen ist. Wir werden in einem 10-schrittigen Vorgehen die "n = 1"-Beobachtungsdaten der einzelnen Teilnehmer auswerten und eine Metaanalyse der zusammengeführten Ergebnissee durchführen.DiskussionUnserer Auffassung nach wird jede einzelne "n = 1"-Studie ein Kapitel mit eigenen Lehren innerhalb eines zehnteiligen Buches sein, welches eine umfassende Darstellung der Wirksamkeit des Homöopathie-Protokolls der sechsten Ausgabe des Organon zur Behandlung von Depressionen ermöglicht.


Assuntos
Transtorno Depressivo Maior , Homeopatia , Feminino , Humanos , Masculino , Estudos Cross-Over , Transtorno Depressivo Maior/terapia , Transtorno Depressivo Maior/etiologia , Método Duplo-Cego , Homeopatia/métodos , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto
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