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The effect of Crocus sativus on several disorders has been discussed or even confirmed, but the efficacy of this herb on the female reproductive system has not been well presented. In this regard, this systematic review comprehensively discussed the efficacy of C. sativus and its main phytochemical compounds on the female reproductive system and its disorders for the first time. In this systematic review, scientific databases, including PubMed, Web of Sciences, Google Scholar, Scopus, and Scientific Information Database, were explored profoundly. In vivo, in vitro, and human studies published until the end of July 2023, which had investigated the pharmacological properties of C. sativus, crocin, crocetin, safranal, or picrocrocin on the female reproductive system, were selected. A total of 50 studies conducted on the effect of C. sativus on the female reproductive system were acquired. These studies confirmed the efficacy of C. sativus or its main phytochemical ingredients in several aspects of the female reproductive system, including regulation of sex hormones, folliculogenesis, ovulation, and protection of the ovary and uterus against several oxidative stress. Several retrieved studies indicated that this herb also can alleviate the symptoms of patients suffering from dysmenorrhea, premenstrual syndrome, menopause, polycystic ovary disease (PCOD), and sexual dysfunction. Furthermore, it is a promising candidate for future studies or even trials regarding ovarian and cervical cancers. This review concluded that C. sativus can improve the symptoms of several female reproductive system disorders, which is particularly due to the presence of phytochemical ingredients, such as crocin, crocetin, and safranal.
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Crocus , Crocus/química , Humanos , Feminino , Extratos Vegetais/farmacologia , Síndrome Pré-Menstrual/tratamento farmacológico , Animais , Carotenoides/farmacologia , Síndrome do Ovário Policístico/tratamento farmacológico , Menopausa/efeitos dos fármacos , Dismenorreia/tratamento farmacológico , Compostos Fitoquímicos/farmacologia , Vitamina A/análogos & derivados , Cicloexenos/farmacologia , Glucosídeos , TerpenosRESUMO
Mountains play a key role in forming biodiversity by acting both as barriers to gene flow among populations and as corridors for the migration of populations adapted to the conditions prevailing at high elevations. The Anatolian and the Zagros Mountains are located in the Alpine-Himalayan belt. The formation of these mountains has influenced the distribution and isolation of the animal population since the late Cenozoic. Apathya is a genus of lacertid lizards distributed along these mountains with two species, i.e., Apathya cappadocica and Apathya yassujica. The taxonomy status of lineages within the genus is complicated. In this study, we tried to collect extensive samples from throughout the distribution range, especially within the Zagros Mountains. Also, we used five genetic markers, two mitochondrial (COI and Cyt b) and three nuclear (C-mos, NKTR, and MCIR), to resolve the phylogenetic relationships within the genus and explain several possible scenarios that shaped multiple genetic structures. The combination of results in the current study indicated eight well-support monophyletic lineages that separated to two main groups; group 1 including A. c. cappadocica, A. c. muhtari and A. c. wolteri, group 2 contains four regional clades Turkey, Urmia, Baneh and Ilam, and finally a single clade belonging to the species A. yassujica. In contrast to previous studies, Apathya cappadocica urmiana was divided into four clades and three clades were recognized within Iranian boundaries. The clades have dispersed from Anatolia to adjacent regions in the south of Anatolia and the western Zagros Mountains. According to the evidence generated in this study this clade is paraphyletic. Based on our assumption, orogeny activities and also climate fluctuations in Middle Miocene and Pleistocene have influenced to formation of lineages. In this study we revisit the taxonomy of the genus and demonstrate that the species diversity was substantially underestimated. Our findings suggest that each of the eight clades corresponding to subspecies and distinct geographic regions deserve to be promoted to species level.
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Lagartos , Animais , Filogenia , Lagartos/genética , Irã (Geográfico) , DNA Mitocondrial/genética , Evolução Biológica , Variação GenéticaRESUMO
OBJECTIVE: To compare the effectiveness of a structured goal-setting and tailored follow-up rehabilitation intervention with existing rehabilitation in patients with rheumatic and musculoskeletal diseases. DESIGN: A pragmatic stepped-wedge cluster randomized trial. SETTING: Eight rehabilitation centers in secondary healthcare, Norway. PARTICIPANTS: A total of 374 adults with rheumatic and musculoskeletal diseases were included in either the experimental (168) or the control group (206). INTERVENTIONS: A new rehabilitation intervention which comprised structured goal setting, action planning, motivational interviewing, digital self-monitoring of goal progress, and individual follow-up support after discharge according to patients' needs and available resources in primary healthcare (the BRIDGE-intervention), was compared to usual care. MAIN MEASURES: Patient-reported outcomes were collected electronically on admission and discharge from rehabilitation, and after 2, 7, and 12 months. The primary outcome was patients' goal attainment measured by the Patient Specific Functional Scale (0-10, 10 best) at 7 months. Secondary outcome measures included physical function (30-s Sit-To-Stand test), health-related quality of life (EQ-5D-5L-index), and self-assessed health (EQ-VAS). The main statistical analyses were performed on an intention-to-treat basis using linear mixed models. RESULTS: No significant treatment effects of the BRIDGE-intervention were found for either primary (Patient Specific Functional Scale mean difference 0.1 [95% CI: -0.5, 0.8], p = 0.70), or secondary outcomes 7 months after rehabilitation. CONCLUSION: The BRIDGE-intervention was not shown to be more effective than existing rehabilitation for patients with rheumatic and musculoskeletal diseases. There is still a need for more knowledge about factors that can improve the quality, continuity, and long-term health effects of rehabilitation for this patient group.
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Doenças Musculoesqueléticas , Qualidade de Vida , Adulto , Humanos , Motivação , HospitalizaçãoRESUMO
The human colon harbors a diverse array of microorganisms that play fundamental roles in colorectal cancer (CRC). Increasing evidence indicates that dysbiosis of the intestinal microbiome has been associated with the development of CRC. Interaction between host genetics, intestinal microbiota, and lifestyle is well-indicated in the influence, prevention, and treatment of CRC. Various microbiome compositions have reported anticancer and/or anti-inflammatory properties. The presence of our microbiota is integral to our development, but a change in its composition can often lead to adverse effects, increasing the propensity for serious diseases like cancers. Recently, molecular detection and metabolomic techniques have increased our knowledge of the role of microbiota in promoting tumorigenesis. Dietary interventions may be appropriate to regulate the growth of beneficial microbiota in the gut. Metagenomic approaches along with immunology and metabolomics will obvious a new path for the treatment of CRC. In this study, we summarized recent advances in understanding the mechanisms involved in microbiota-related colorectal carcinoma, based on evidence from immunotherapy studies.
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Neoplasias Colorretais , Microbioma Gastrointestinal , Microbiota , Humanos , Neoplasias Colorretais/terapia , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/patologia , Disbiose/terapia , ImunoterapiaRESUMO
The issue of treating Multiple Sclerosis (MS) begins with disease-modifying treatments (DMTs) which may cause lymphopenia, dyspnea, and many other adverse effects. Consequently, further identification and evaluation of alternative treatments are crucial to monitoring their long-term outcomes and hopefully, moving toward personalized approaches that can be translated into clinical treatments. In this article, we focused on the novel therapeutic modalities that alter the interaction between the cellular constituents contributing to MS onset and progression. Furthermore, the studies that have been performed to evaluate and optimize drugs' efficacy, and particularly, to show their limitations and strengths are also presented. The preclinical trials of novel approaches for multiple sclerosis treatment provide promising prospects to cure the disease with pinpoint precision. Considering the fact that not a single treatment could be effective enough to cover all aspects of MS treatment, additional researches and therapies need to be developed in the future. Since the pathophysiology of MS resembles a jigsaw puzzle, researchers need to put a host of pieces together to create a promising window towards MS treatment. Thus, a combination therapy encompassing all these modules is highly likely to succeed in dealing with the disease. The use of different therapeutic approaches to re-induce self-tolerance in autoreactive cells contributing to MS pathogenesis is presented. A Combination therapy using these tools may help to deal with the clinical disabilities and symptoms of the disease in the future.
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Esclerose Múltipla , Ácidos Nucleicos , Humanos , Esclerose Múltipla/tratamento farmacológico , Ácidos Nucleicos/uso terapêuticoRESUMO
Multiple sclerosis (MS) is a chronic autoimmune disorder of central nervous system which is increasing worldwide. Although immunosuppressive agents are used for the treatment of MS disease, nevertheless the lack of non-toxic and efficient therapeutic method is perceptible. Hence, this study aims to evaluate the effect of Contactin-associated protein (Caspr) antibody-, poly ethylene glycol (PEG)- and exosome combined gold nanoparticles (GNPs) in comparison to Glatiramer acetate as a selective treatment of MS disease in the experimental autoimmune encephalomyelitis (EAE) mouse model. EAE was induced in female C57BL/6 mice and 25-day treatment with anti-Caspr-, PEG- and exosome combined GNPs was evaluated. Histopathological examination of spinal cord, regulatory T cells as well as inflammatory pathway including IFN-É£ and IL-17 and mir-326 were investigated. The results showed the severity of MS symptoms was significantly decreased in all treated groups. Histological examination of the spinal cord indicated the reduced demyelination and immune cell infiltration. Besides, regulatory T cells were significantly increased following all treatments. Remarkably, the cytokine levels of IFN-É£ and IL-17 as well as mir-326 is altered in treated groups. Taken together, the obtained findings demonstrate that the administration of anti-Caspr-, PEG- and exosome combined GNPs can be considered a potential treatment in MS disease.
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Encefalomielite Autoimune Experimental , Nanopartículas Metálicas , Esclerose Múltipla , Animais , Feminino , Camundongos , Contactinas , Citocinas/metabolismo , Modelos Animais de Doenças , Etilenoglicóis , Acetato de Glatiramer/farmacologia , Acetato de Glatiramer/uso terapêutico , Ouro , Imunossupressores/farmacologia , Imunossupressores/uso terapêutico , Interleucina-17 , Nanopartículas Metálicas/uso terapêutico , Camundongos Endogâmicos C57BL , Esclerose Múltipla/tratamento farmacológico , Esclerose Múltipla/patologiaRESUMO
BACKGROUND: The quality of provided health care may be an important source of variation in rehabilitation outcomes, increasing the interest in associations between quality indicators (QIs) and improved patient outcomes. Therefore, we examined the associations between the quality of rehabilitation processes and subsequent clinical outcomes among patients with rheumatic and musculoskeletal diseases (RMDs). METHODS: In this multicentre prospective cohort study, adults with RMDs undergoing multidisciplinary rehabilitation at eight participating centres reported the quality of rehabilitation after 2 months and outcomes after 2, 7, and 12 months. We measured perceived quality of rehabilitation by 11 process indicators that cover the domains of initial assessments, patient participation and individual goal-setting, and individual follow-up and coordination across levels of health care. The patients responded "yes" or "no" to each indicator. Scores were calculated as pass rates (PRs) from 0 to 100% (best score). Clinical outcomes were goal attainment (Patient-Specific Functional Scale), physical function (30 s sit-to-stand test), and health-related quality of life (EuroQoL 5D-5L). Associations between patient-reported quality of care and each outcome measure at 7 months was analysed by linear mixed models. RESULTS: A total of 293 patients were enrolled in this study (mean age 52 years, 76% female). Primary diagnoses were inflammatory rheumatic disease (64%), fibromyalgia syndrome (18%), unspecific neck, shoulder, or low back pain (8%), connective tissue disease (6%), and osteoarthritis (4%). The overall median PR for the process indicators was 73% (range 11-100%). The PR was lowest (median 40%) for individual follow-up and coordination across levels of care. The mixed model analyses showed that higher PRs for the process indicators were not associated with improved goal attainment or improved physical function or improved health-related quality of life. CONCLUSIONS: The quality of rehabilitation processes was not associated with important clinical outcomes. An implication of this is that measuring only the outcome dimension of quality may result in incomplete evaluation and monitoring of the quality of care, and we suggest using information from both the structure, process, and outcome dimensions to draw inferences about the quality, and plan future quality initiatives in the field of complex rehabilitation. TRIAL REGISTRATION: The study is part of the larger BRIDGE trial (ClinicalTrials.gov NCT03102814 ).
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Doenças Musculoesqueléticas , Qualidade de Vida , Adulto , Estudos de Coortes , Atenção à Saúde , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Doenças Musculoesqueléticas/reabilitação , Doenças Musculoesqueléticas/terapia , Estudos Prospectivos , Resultado do TratamentoRESUMO
Multiple sclerosis (MS) is a central nervous system (CNS) degenerative disorder which is caused by a targeted autoimmune-mediated attack on myelin proteins. Previously, mesenchymal stem cells were considered as a novel and successful treatment of MS. One of the underlying mechanisms behind their immunomodulatory function is the release of extracellular vesicles, particularly exosomes. In this study, we aimed to evaluate the suppressive efficacy of MSCs and their exosomes on the proliferation of peripheral mononuclear blood cells (PBMC) in relapsing-remitting MS (RRMS) patients and healthy subjects. To do, mesenchymal stem cells were derived from human umbilical cord tissues and used for exosome isolation through ultracentrifugation. Suppressive function of MSCs and MSC-derived exosomes was examined in a coculture with CFSE-labelled PBMCs in vitro. PBMC proliferation of the patients and healthy individuals was measured using flow cytometry. We first demonstrated that proliferation of PBMCs decreased in the presence of MSCs and suppression was more efficient by MSC-derived exosomes, with a minimum alloreaction rate. However, suppression capacity of MSCs and their exosomes significantly decreased during extensive sub-culturing. The present study showed that MSC-derived exosomes as an effective cell-free therapy could prevent proliferation of PBMCs. However, further evaluations are need to move towards a functional approach that can be translated to the clinic.
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Exossomos/metabolismo , Leucócitos Mononucleares/imunologia , Leucócitos Mononucleares/metabolismo , Células-Tronco Mesenquimais/metabolismo , Esclerose Múltipla/imunologia , Esclerose Múltipla/metabolismo , Cordão Umbilical/citologia , Adulto , Biomarcadores , Diferenciação Celular , Proliferação de Células , Separação Celular/métodos , Células Cultivadas , Exossomos/ultraestrutura , Feminino , Humanos , Imunofenotipagem , Masculino , Células-Tronco Mesenquimais/citologia , Esclerose Múltipla/patologiaRESUMO
BACKGROUND: Quality of care is gaining increasing attention in research, clinical practice, and health care planning. Methods for quality assessment and monitoring, such as quality indicators (QIs), are needed to ensure health services in line with norms and recommendations. The aim of this study was to assess the responsiveness of a newly developed QI set for rehabiliation for people with rheumatic and musculoskeletal diseases (RMDs). METHODS: We used two yes/no questionnaires to measure quality from both the provider and patient perspectives, scored in a range of 0-100% (best score, 100%). We collected QI data from a multicenter stepped-wedge cluster-randomized controlled trial (the BRIDGE trial) that compared traditional rehabilitation with a new BRIDGE program designed to improve quality and continuity in rehabilitation. Assessment of the responsiveness was performed as a pre-post evaluation: Providers at rehabilitation centers in Norway completed the center-reported QIs (n = 19 structure indicators) before (T1) and 6-8 weeks after (T2) adding the BRIDGE intervention. The patient-reported QIs comprised 14 process and outcomes indicators, measuring quality in health services from the patient perspective. Pre-intervention patient-reported data were collected from patients participating in the traditional program (T1), and post-intervention data were collected from patients participating in the BRIDGE program (T2). The patient groups were comparable. We used a construct approach, with a priori hypotheses regarding the expected direction and magnitude of PR changes between T1 and T2. For acceptable responsivess, at least 75% of the hypotheses needed to be confirmed. RESULTS: All eight participating centers and 82% of the patients (293/357) completed the QI questionnaires. Responsiveness was acceptable, with 44 of 53 hypotheses (83%) confirmed for single indicators and 3 of 4 hypotheses (75%) confirmed for the sum scores. CONCLUSION: We found this QI set for rehabilitation to be responsive when applied in rehabilitation services for adults with various RMD conditions. We recommend this QI set as a timely method for establishing quality-of-rehabilitation benchmarks, promoting important progress toward high-quality rehabilitation, and tracking trends over time. TRIAL REGISTRATION: The study is part of the larger BRIDGE trial, registered at ClinicalTrials.gov (Identifier: NCT03102814).
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Continuidade da Assistência ao Paciente , Doenças Musculoesqueléticas , Indicadores de Qualidade em Assistência à Saúde , Centros de Reabilitação/normas , Doenças Reumáticas , Adulto , Benchmarking , Humanos , Estudos Multicêntricos como Assunto , Doenças Musculoesqueléticas/reabilitação , Noruega , Ensaios Clínicos Controlados Aleatórios como Assunto , Doenças Reumáticas/reabilitação , Inquéritos e QuestionáriosRESUMO
BACKGROUND: During the last decade, several studies have evaluated the potential association between vitamin D receptor (VDR) gene polymorphism and susceptibility to asthma. In spite of valuable findings, the results are still contradictory. Therefore, a comprehensive meta-analysis not only solves discrepancies but provides a clue for future projects. OBJECTIVE: This meta-analysis was performed to identify whether VDR gene polymorphisms (FokI (rs2228570) or TaqI (rs731236) or BsmI (rs1544410) or ApaI (rs7975232)) play a role in the risk of asthma. METHODS: Electronic search of Web of Science, Scopus, and PubMed databases were systematically conducted from their inception until June 2019, to identify all published studies. Eligibility of the studies was confirmed by precise inclusion and exclusion criteria, and the resultant studies were analyzed. RESULTS: A total of 17 studies concerning VDR gene polymorphisms and asthma risk were included in this meta-analysis. The results of pooled analysis indicated a statistically significant association between FokI SNP (dominant model [OR = 0.78, 95% CI, 0.62-0.98, random effect model] and allelic model [OR = 0.81, 95% CI, 0.67-0.98, random effect model]) and TaqI SNP (homozygote contract model [OR = 0.70, 95% CI, 0.54-0.89]) with asthma risk. Moreover, subgroup analysis showed that ethnicity influences asthma risk in Asian, African, and American populations. The sensitivity analyses confirmed the stability of the results. CONCLUSION: This meta-analysis suggests that VDR gene polymorphism is associated with the risk of asthma.
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Asma/genética , Predisposição Genética para Doença/genética , Receptores de Calcitriol/genética , Adolescente , Adulto , Povo Asiático/genética , População Negra/genética , Estudos de Casos e Controles , Criança , Feminino , Estudos de Associação Genética , Humanos , Masculino , Pessoa de Meia-Idade , Polimorfismo de Nucleotídeo Único/genética , População Branca/genéticaRESUMO
BACKGROUND: Multiple sclerosis (MS) is a chronic and autoimmune disease of the central nervous system (CNS), mainly characterized by inflammatory demyelination, which manifests as relapses and diffuse damage and brain volume loss, both accounting for neurodegeneration, and therefore, physical disability. MS typically affects young adults and is commonly diagnosed in the early years by acute relapses, which then followed through partial or complete remission period. The clinical course of MS is characterized as four major classifications, including relapsing-remitting (RRMS), primary progressive (PPMS), progressive relapsing (PRMS), and secondary progressive (SPMS). PURPOSE: This review provides comprehensive overview of the current treatments and future innovative approaches in the treatment of MS. RESULTS: Currently, there is no definite cure for MS. The treatment of MS has mainly been based on the prescription of immunosuppressive and immune-modulating agents. However, a number of disease-modifying treatments (DMTs) have been designed that reduce the attack rate and delay progression and mainly target inflammation settings in these patients. Although remarkable advancements have occurred in the therapy of MS, the rate of progressive disability and early mortality is still worrisome. Recently, a monoclonal antibody (ocrelizumab) was demonstrated to be beneficial in a clinical trial of primary progressive MS. Furthermore, novel treatment strategies concentrating on the remyelination or neuroprotection are under evaluation. CONCLUSIONS: In spite of prosperous experiences in MS therapy, the future research, hopefully, will bring substantial improvements in the understanding and approaches of MS therapy.
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Esclerose Múltipla/terapia , Animais , Transplante de Medula Óssea , Drogas em Investigação/uso terapêutico , Epigênese Genética , Humanos , Transplante de Células-Tronco Mesenquimais , Esclerose Múltipla/imunologia , Bainha de Mielina , Linfócitos TRESUMO
BACKGROUND AND AIM: Recent evidence indicates that new approach of the diet with low fermentable oligo-di-mono-saccharides and polyols (FODMAPs) may have an effective role in management of the patients with irritable bowel syndrome (IBS). We compared the results of low FODMAP diet with current dietary treatment, general dietary advices (GDA), on the clinical response in patients with diarrhea subtype of IBS (IBS-D). METHODS: In this randomized, controlled, single-blind trial, we included 110 patients with IBS-D in two intervention groups. Participants were randomly assigned to the low FODMAP diet (n = 55) and GDA (n = 55) for 6 weeks after a 10-day screening period. Gastrointestinal symptoms and bowel habit status were evaluated using a symptom severity scoring system and Bristol stool form scale pre-intervention and post-intervention. Patients completed 3-day food diary before and after the intervention. RESULTS: Of 110 patients, 101 completed the dietary interventions. At the baseline, the nutrient intake, severity of symptoms, and demographic data were similar between two groups. After 6 weeks, the low FODMAP diet improves significantly overall gastrointestinal symptoms scores, stool frequency, and consistency versus GDA group (P < 0.001, P < 0.001, and P = 0.003, respectively). Compared with the baseline, both intervention groups expressed a significant reduction in overall scores of symptom severity scoring system, abdominal pain, distension, consistency, and frequency, but this reduction is greater in low FODMAP diet group. CONCLUSIONS: Both low FODMAP diet and GDA in patients with IBS-D led to adequate improvement of gastrointestinal symptoms for 6 weeks. However, the low FODMAP diet has greater benefits in IBS improvement.
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Diarreia/dietoterapia , Diarreia/etiologia , Dieta com Restrição de Carboidratos/métodos , Aconselhamento Diretivo , Dissacarídeos/administração & dosagem , Síndrome do Intestino Irritável/dietoterapia , Monossacarídeos/administração & dosagem , Polímeros/administração & dosagem , Adulto , Feminino , Fermentação , Humanos , Síndrome do Intestino Irritável/complicações , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
Two categories of regulatory T cells (Tregs), nTreg and iTreg, play vital roles in orchestrating the integrity of a host in the course of an immune response. Tregs commonly belong to CD4+ CD25+ T cells and they are characterized by a transcription factor - forkhead box P3 (FoxP3). Within the space of the last few years, interests have been drawn to Tregs as a therapeutic tool in several settings like autoimmune disease, transplantation, and tumor disorders. As a consequence, to assess the functional properties of Tregs, namely through their ability to suppress other cells, cytokine expression, and proliferation in a variety of conditions, it is mandatory to gain better approaches to this end. This would be beneficial in designing better-than-ever therapeutic methods with regard to Tregs properties. Gaining better insights into the underlying mechanisms of immune regulation, by means of straightforward and less time-consuming techniques, will hopefully permit the therapeutic application of these cells in the control of human disorders. This review aims at going through the basic methods for Treg isolation as well the efficiency of the commonly exerted in vitro assays of Tregs-mediated immune suppression.
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Imunoterapia , Subpopulações de Linfócitos T/fisiologia , Linfócitos T Reguladores/fisiologia , Animais , Antígenos CD4/metabolismo , Fatores de Transcrição Forkhead/metabolismo , Humanos , Tolerância Imunológica , Imunoensaio , Subunidade alfa de Receptor de Interleucina-2/metabolismoRESUMO
This study explores how climate variables influenced the evolution and diversification of Neurergus newts within the Irano-Anatolian biodiversity hotspot. We use a dated phylogenetic tree and climatic niche models to analyze their evolutionary history and ecological preferences. Using genetic data from nuclear (KIAA) and mitochondrial (16s and 12s) genes, we estimate divergence times and identify four major Neurergus clades. The initial speciation event occurred approximately 11.3 million years ago, coinciding with the uplift of the Zagros and Anatolian mountains. This geological transformation isolated newt populations, likely triggering the first speciation event. By integrating potential geographic distribution with climate variables, we reconstruct ancestral niche occupancy profiles. This highlights the critical roles of temperature and precipitation in shaping Neurergus habitat preferences and distribution. We observe both phylogenetic niche conservatism and divergence, with niche divergence playing a dominant role in diversification. This research emphasizes the complex interplay of geography, climate, and ecology in speciation and the vulnerability of isolated mountain newt populations to environmental changes.
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INTRODUCTION: Irritable bowel syndrome (IBS) is associated with a high prevalence of anxiety and depression. This study aimed to evaluate the effects of a traditional Persian herbal formula containing Melissa officinalis, Pimpinella anisum, and Rosa damascena (MPR) on anxiety and depression in IBS patients with symptoms of constipation-predominant IBS (IBS-C). METHODS: This double-blind randomized clinical trial was conducted in Afzalipour Hospital via block randomization method. A total of 96 IBS-C patients (based on Rome IV criteria), aged 18-60 years, were included in this study. Participants received capsules containing either 500 mg of herbal formula or placebo (cornstarch) twice a day for four weeks Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale. RESULTS: Forty-three patients in the intervention group and 45 patients in the control group completed this study. Except for the education level, there were no significant differences in the demographic characteristics between the two groups (P > 0.05). The mean levels of anxiety and depression, and total IBS symptom severity score showed no significant differences between the two groups at baseline (P > 0.05). After four weeks of treatment, the anxiety score considerably improvement in the treatment group (Cohen's d = -1.19, 95 % confidence intervals [CIs] -4.49 to 2.13), as did the depression score (Cohen's d = -1.93, 95 % CIs -4.32 to 2.79). CONCLUSION: MPR considerably improved anxiety and depression in patients with IBS-C compared to the placebo without serious side effects.
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INTRODUCTION: Functional dyspepsia (FD) is one of the most prevalent chronic disorders affecting up to 30% of the world population with considerable impairment of quality of life. This study evaluated the efficacy of the herbal preparation of Bunium persicum (Boiss.) B.Fedtsch. and Coriandrum sativum L. on symptom severity, symptom frequency, and quality of life of patients with FD. METHODS: This double-blind randomized controlled clinical trial, with parallel groups allocation ratio of 1:1, was conducted in a referral clinic of Afzalipour Hospital affiliated with Kerman University of Medical Sciences in Kerman, southeastern Iran. A total of 90 patients with FD (diagnosed based on the Rome IV criteria) were included in this study. The patients with complications during the intervention, pregnancy or lactation, a history of allergy to herbal drugs, use of other medication that affect the symptoms of FD during the study, and severe organic or psychiatric disorders were excluded. The participants received one capsule containing 500 mg of herbal preparation or placebo twice a day for 4 weeks and were subsequently followed up for 4 more weeks. Clinical outcomes were assessed via the Dyspepsia Severity Questionnaire, the Rome IV Diagnostic Questionnaire, and Nepean Dyspepsia Index Questionnaire. RESULTS: A total 40 participants in each group completed the follow-up period, and their data were analyzed statistically. All clinical outcomes showed significant improvements by herbal preparation compared to the placebo without serious side effects (p < 0.05). CONCLUSIONS: This herbal preparation can significantly improve the quality of life, and symptoms of FD compared to placebo.
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PURPOSE: To investigate how a quality improvement program (BRIDGE), designed to promote coordination and continuity in rehabilitation services, was delivered and perceived by providers in routine practice for patients with rheumatic and musculoskeletal diseases. METHODS: A convergent mixed methods approach was nested within a stepped-wedge, randomized controlled trial. The intervention program was developed to bridge gaps between secondary and primary healthcare, comprising the following elements: motivational interviewing; patient-specific goal setting; written rehabilitation-plans; personalized feedback on progress; and tailored follow-up. Data from health professionals who delivered the program were collected and analyzed separately, using two questionnaires and three focus groups. Results were integrated during the overall interpretation and discussion. RESULTS: The program delivery depended on the providers' skills and competence, as well as on contextual factors in their teams and institutions. Suggested possibilities for improvements included follow-up with sufficient support from next of kin and external services, and the practicing of action and coping plans, standardized outcome measures, and feedback on progress. CONCLUSIONS: Leaders and clinicians should discuss efforts to ensure confident and qualified rehabilitation delivery at the levels of individual providers, teams, and institutions, and pay equal attention to each component in the process from admission to follow-up.
Quality in rehabilitation should be characterized by a continuous and coordinated process from goal setting to follow-up.To improve the quality, sufficient involvement of next of kin and external services is needed.Clinicians may need training to build confidence in motivational interviewing, action- and coping planning, feedback on progress, and follow-up.Leaders should organize education sessions, optimize schedules, insert standardized outcome measures, and facilitate collaboration across levels of care and services.
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Doenças Musculoesqueléticas , Melhoria de Qualidade , Humanos , Avaliação de Resultados em Cuidados de Saúde , Pessoal de SaúdeRESUMO
The recurrent COVID-19 infection, despite global vaccination, highlights the need for booster doses. A heterologous booster has been suggested to enhance immunity and protection against emerging variants of concern of the SARS-CoV-2 virus. In this report, we aimed to assess the safety, and immunogenicity of COReNAPCIN, as a fourth booster dose after three doses of inactivated vaccines. METHODS: The study was conducted as a double-blind, randomized, placebo-controlled phase 1 clinical trial of the mRNA-based vaccine candidate, COReNAPCIN. The vaccine was injected as a heterologous booster in healthy Iranian adults aged 18-50 who had previously received three doses of inactivated SARS-CoV-2 vaccines. In the study, 30 participants were randomly assigned to receive either COReNAPCIN in two different doses (25 µg and 50 µg) or placebo. The vaccine candidate contained mRNA encoding the complete sequence of the pre-fusion stabilized Spike protein of SARS-CoV-2, formulated within lipid nanoparticles. The primary endpoint was safety and the secondary objective was humoral immunogenicity until 6 months post-vaccination. The cellular immunogenicity was pursued as an exploratory outcome. RESULTS: COReNAPCIN was well tolerated in vaccinated individuals in both doses with no life-threatening or other serious adverse events. The most noticeable solicited adverse events were pain at the site of injection, fatigue and myalgia. Regarding the immunogenicity, despite the seroprevalence of SARS-CoV-2 antibodies due to the vaccination history for all and previous SARS-CoV-2 infection for some participants, the recipients of 25 and 50 µg COReNAPCIN, two weeks post-vaccination, showed 6·6 and 8·1 fold increase in the level of anti-RBD, and 11·5 and 21·7 fold increase in the level of anti-spike antibody, respectively. The geometric mean virus neutralizing titers reached 10.2 fold in the 25 µg group and 8.4 fold in 50 µg group of pre-boost levels. After 6 months, the measured anti-spike antibody concentration still maintains a geometric mean fold rise of 2.8 and 6.3, comparing the baseline levels in 25 and 50 µg groups, respectively. Additionally, the significant increase in the spike-specific IFN-Ï T-cell response upon vaccination underscores the activation of cellular immunity. CONCLUSION: COReNAPCIN booster showed favorable safety, tolerability, and immunogenicity profile, supporting its further clinical development (Trial registration: IRCT20230131057293N1).
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Anticorpos Antivirais , Vacinas contra COVID-19 , COVID-19 , Imunização Secundária , SARS-CoV-2 , Humanos , Adulto , Masculino , Método Duplo-Cego , Feminino , Vacinas contra COVID-19/imunologia , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/administração & dosagem , Irã (Geográfico) , SARS-CoV-2/imunologia , Adulto Jovem , COVID-19/prevenção & controle , COVID-19/imunologia , Pessoa de Meia-Idade , Anticorpos Antivirais/sangue , Imunogenicidade da Vacina , Glicoproteína da Espícula de Coronavírus/imunologia , Anticorpos Neutralizantes/sangue , Vacinas de mRNA , Adolescente , SeguimentosRESUMO
Purpose: To identify and describe behavior change techniques (BCTs) used in rehabilitation for patients with rheumatic and musculoskeletal diseases (RMDs), according to their own perceptions. Further, to examine patients' descriptions of their capability, opportunity, motivation, and readiness for health behavior change. Patients and Methods: Patients were adults in need of specialized, multidisciplinary rehabilitation services due to inflammatory rheumatic disease, systemic connective tissue disease, or fibromyalgia / chronic widespread pain. Semi-structured interviews of 21 patients were analyzed with deductive qualitative content analysis applying three theoretical frameworks: the Behavior Change Technique Taxonomy, the transtheoretical model and stages of change, and the capability, opportunity, and motivation model of behavior. Results: Forty-six BCTs aggregated within 14 BCT groups were identified used by either patients, healthcare professionals (HPs), or both. Goals and planning, feedback and monitoring, social support, shaping knowledge, repetition and substitution were most frequently used to facilitate behavior change. Twenty patients had reached the action stage and made specific lifestyle changes concerning more than half of their goals. Concerning other goals, 6 of these patients reported to be contemplating behavior change and 15 to be preparing for it. The rehabilitation process appeared to strengthen capability, opportunity, motivation, and the desired behaviors. Patient-reported barriers to behavior change were connected with restrictions in physical capability resulting from an unpredictable and fluctuating disease course, weakened motivation, and contextual factors, such as lack of access to healthcare support and training facilities, and high domestic care burden. Conclusion: The rehabilitation process seemed to strengthen individual and contextual prerequisites for behavior change and facilitate the use of required techniques and engagement in the desired behaviors. However, patients with RMDs may need prolonged support from HPs to integrate healthy lifestyle changes into everyday life. The findings can be used to optimize rehabilitation interventions and patients' persistent engagement in healthy behaviors.
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PURPOSE: To explore what patients with rheumatic and musculoskeletal diseases (RMDs) need and receive of follow-up care after specialized rehabilitation, and whether received follow-up is associated with health outcomes after 1 year. Further, to compare these findings with patients' experiences to improve the understanding of how follow-up takes place. METHODS: In a mixed methods study, patients received a rehabilitation programme designed to improve the continuity in rehabilitation across care levels. A total of 168 patients completed questionnaires, of which 21 were also interviewed. RESULTS: At discharge, most patients reported needs for follow-up. These needs were largely met within 1 year, mainly resulting from patients' initiatives to re-connect with previous contacts. The degree of received follow-up was not associated with goal attainment, quality of life, or physical function. Factors related to providers (competence, communication skills), context (delays, limited access to care), and patients (motivation, life situation, preferences) seemed to be decisive for the progress of the rehabilitation process over time. CONCLUSIONS: The results provide evidence that access to follow-up care is crucial to patients with RMDs. However, it also highlights several factors that may influence its impact. These results can be used to optimise design and implementation of future follow-up interventions.
Healthcare providers should take greater responsibility for creating continuity in rehabilitation across levels of care.Follow-up care should be adapted to patients' needs, goals, and preferences as regards content, timing, and mode of delivery.Follow-up should be linked to a rehabilitation plan for each patient to ensure continuity of care.More effective communication systems across service levels should be established.