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Background: The rising prevalence of familial multiple sclerosis (MS) in Iran has spurred interest in the potential impact of parental consanguinity on the risk of developing the disease. This study aims to aggregate current knowledge on parental consanguinity and its possible effect on MS risk, particularly among familial MS patients from various regions and ethnicities in Iran. The objective is to enhance the understanding of MS genetics and encourage further research in this field. Materials and methods: A cross-sectional study was conducted on clinically definite familial MS (FMS) patients registered in the nationwide MS registry of Iran (NMSRI). Data were extracted and supplemented with structured telephone follow-ups to gather detailed histories of MS in relatives and the familial relationships of the patients' parents. A family penetration score was proposed. Descriptive statistics and inferential statistical tests were used to analyze the data at a significance level of 0.05, adhering to ethical guidelines. Results: Out of 19,911 individuals registered in the NMSRI, 2307 FMS patients across 13 provinces were included in the final analysis. Among these, 385 (19.3 %) reported parental consanguinity, with 283 (14.2 %) having parents who were cousins and 102 (5.1 %) having parents who were distant relatives. The data showed no significant association between parental kinship and variables such as MS phenotype, number of affected relatives with MS, hospitalization rates, and expanded disability status scale score. Similarly, MS severity did not differ based on parental consanguinity (P-value >0.05). While the rate of consanguineous marriage was higher among patients with an onset age less than 18 years, there was no statistically significant difference in disease onset age based on parental consanguinity status. Conclusion: Our study highlights the complexity of factors influencing MS development, including genetic and environmental components. These results highlight the need for further research to achieve a more comprehensive understanding of MS etiology.
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BACKGROUND: Multiple sclerosis (MS), as an autoimmune disease of the central nervous system (CNS), has a significant burden among people worldwide. Tobacco smoking is one of the most prevalent habits of patients with different diseases including those with MS and among the methods of use, waterpipe tobacco smoking is gaining popularity. Herein, we aimed to systematically evaluate the association between waterpipe smoking and MS. METHODS: Relevant studies were identified to be included in this systematic review and meta-analysis through a systematic search in PubMed, Scopus, Web of Science, and Embase. Studies were screened by title/abstract and then by their full text. Extraction of data was performed for relevant studies. Odds ratios (OR) and their 95% confidence intervals (CIs) of the association between waterpipe smoking and MS were used to pool the results observed in each study. RESULTS: After the screening, a total of five studies were included in our systematic review, comprised of 3087 individuals, among which there were 1135 cases with MS. Random-effect meta-analysis revealed that ever-smoking waterpipe had a significant association with MS (OR 1.73, 95% CI 1.38-2.17, p-value <0.0001). Similarly, past waterpipe smoking was significantly higher in those with MS, compared with controls (OR 2.17, 95% CI 1.61-2.92, p-value < 0.0001). Based on the reported results, smoking both tobacco and waterpipe had an additive association with MS. Finally, no association was found between the Expanded Disability Status Scale (EDSS) and waterpipe smoking. CONCLUSION: Waterpipe as one of the common ways of tobacco smoking becoming popular has an association with MS and even the use of waterpipe for a certain period in the lifetime has a significant correlation with MS. Further large-scale studies are needed to confirm these findings. These results could help clinicians in risk-stratifying the patients and to provide better care for the MS population.
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Comorbidities in patients with multiple sclerosis (MS) and antibody-mediated diseases of the central nervous system (CNS) including neuromyelitis optica spectrum disorder (NMOSD), and myelin oligodendrocyte glycoprotein (MOG)-antibody-associated disease (MOGAD) are common and may influence the course of their neurological disease. Comorbidity may contribute to neuronal injury and therefore limit recovery from attacks, accelerate disease progression, and increase disability. This study aims to explore the impact of comorbidity, particularly vascular comorbidity, and related risk factors on clinical and paraclinical parameters of MS, NMOSD and MOGAD. We propose COMMIT, a prospective multicenter study with longitudinal follow-up of patients with MS, NMOSD, and MOGAD, with or without comorbidities, as well as healthy subjects as controls. Subjects will be stratified by age, sex and ethnicity. In consecutive samples we will analyze levels of inflammation and neurodegeneration markers in both fluid and cellular compartments of the peripheral blood and cerebrospinal fluid (CSF) using multiple state-of-the-art technologies, including untargeted proteomics and targeted ultrasensitive ELISA assays and quantitative reverse transcription polymerase chain reaction (RT-qPCR) as well as high-dimensional single-cell technologies i.e., mass cytometry and single-cell RNA sequencing. Algorithm-based data analyses will be used to unravel the relationship between these markers, optical coherence tomography (OCT) and magnetic resonance imaging (MRI), and clinical outcomes including frequency and severity of relapses, long-term disability, and quality of life. The goal is to evaluate the impact of comorbidities on MS, NMOSD, and MOGAD which may lead to development of treatment approaches to improve outcomes of inflammatory demyelinating diseases of the CNS.
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Comorbilidad , Esclerosis Múltiple , Neuromielitis Óptica , Humanos , Esclerosis Múltiple/epidemiología , Esclerosis Múltiple/inmunología , Estudios Prospectivos , Neuromielitis Óptica/epidemiología , Neuromielitis Óptica/inmunología , Neuromielitis Óptica/diagnóstico , Masculino , Femenino , Glicoproteína Mielina-Oligodendrócito/inmunología , Adulto , Biomarcadores/sangre , Autoanticuerpos/sangre , Autoanticuerpos/inmunología , Persona de Mediana EdadRESUMEN
BACKGROUND: Multiple Sclerosis (MS) a central nervous system autoimmune disorder, mainly affecting young adults and more prevalent among women, can lead to sexual dysfunction (SD) among both males and females with MS. Female sexual dysfunction can be defined as dyspareunia, a lack of sexual desire, disorders in the arousal and orgasm phases, and sexual pain disorders. The purpose of this study is to investigate the changes in sexual function among females with MS whose treatment was switched from first-line injectable medications to other agents after a six-month duration. And assess the changes in all three domains of SD. METHODS: In this longitudinal study females diagnosed with MS, aged between 18 and 50 years old, and were candidates for switching their treatment from interferon beta-1a (intra-muscular and subcutaneous), and Glatiramer Acetate (GA), to Fingolimod, Dimethyl Fumarate (DMF), or Natalizumab (NTZ) due to patients' convenience and tolerability and adverse events were included. "Multiple Sclerosis Intimacy and Sexuality Questionnaire-19" was used to evaluate the SD changes before and six months after the new treatment initiation. Statistical analysis was conducted using SPSS V.24 software. Histograms and the Shapiro-Wilk test were used to assess the normality of the variables; due to the non-normal distribution of quantitative variables (except for age), the Wilcoxon signed-rank test was used to compare the scores, before and six months after the medication change. The level of significance was considered less than 0.05. RESULTS: Out of 107 female participants (average age: 35.09 ± 5.61), The mean of overall MSISQ-19 scores, before and six months after the medication change were not significant (p-value = 0.091). However, considering the subdomains, the medication changes only affected the tertiary subdomain of MSISQ-19 (p-value = 0.017). Still, the scores of other subdomains did not change significantly (p-value = 0.761 for primary SD and 0.479 for secondary SD). Also, there wasn't any significant difference between EDSS before and after the medication change (p-value = 0.461). CONCLUSIONS: To our knowledge, this was the first study, assessing the effect of MS medication change on the improvement of SD among patients. According to the results of the presented cross-sectional study, we found that during a six-month period, the tertiary subdomain of MSISQ-19 symptoms improved significantly, while the changes in other SD domains were not significant.
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Acetato de Glatiramer , Esclerosis Múltiple , Disfunciones Sexuales Fisiológicas , Humanos , Femenino , Adulto , Esclerosis Múltiple/tratamiento farmacológico , Esclerosis Múltiple/complicaciones , Persona de Mediana Edad , Disfunciones Sexuales Fisiológicas/etiología , Disfunciones Sexuales Fisiológicas/tratamiento farmacológico , Estudios Longitudinales , Acetato de Glatiramer/administración & dosificación , Acetato de Glatiramer/uso terapéutico , Adulto Joven , Factores Inmunológicos/administración & dosificación , Factores Inmunológicos/uso terapéutico , Dimetilfumarato/administración & dosificación , Dimetilfumarato/uso terapéutico , Adolescente , Inmunosupresores/uso terapéutico , Inmunosupresores/administración & dosificación , Interferón beta-1a/administración & dosificación , Interferón beta-1a/uso terapéutico , Sustitución de Medicamentos/métodos , Clorhidrato de Fingolimod/uso terapéutico , Clorhidrato de Fingolimod/administración & dosificación , Natalizumab/administración & dosificación , Natalizumab/uso terapéuticoRESUMEN
BACKGROUND: A targeted structure for recording, monitoring, and follow-up of patients with neuromyelitis optica spectrum disorders (NMOSD) is in demand. To obtain the correct and uniform standardized information registry system, it is necessary to use a data set that has good validity to help policy-makers systematically plan for improvements in the quality of care. The main goal of the present study was to develop a NMOSD data set for the national registry system in Iran (NMORI) and to evaluate the validity of the presented data set. METHODS: The NMORI data set consisted of baseline characteristics, disease and exposure history, background and past medical history, diagnosis and treatment, clinical features, imaging, and para-clinical findings. The content validity was evaluated by 18 experts from Iran, Japan, and Denmark by scoring each of the questionnaire items in term of transparency, simplicity, and relevance. According to the points given, the content validity index (CVI) and content validity ratio (CVR) scores were calculated and compared with the critical limit. RESULTS: The current study was designed as a 125-items data set which was considered valid. In terms of relevance 110 out of 125 items, simplicity 113 out of 125 items, and transparency 123 out of 125 items had Item-CVI>0.79. All Scale-level-CVI values were greater than 0.9, showing noticeable content validity. In this data set, 112 items had CVR > 0.49, which was considered an acceptable level of significance. CONCLUSION: The implementing of NMORI is important in a developing country such as Iran with significant increasing prevalence of this disease. This registry facilitates a uniform and valid diagnosis and is considered valid for clinical investigation and epidemiological research on NMOSD. Scientists and healthcare policymakers can rely on a validated data set in order to have access to accurate data.
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Neuromielitis Óptica , Sistema de Registros , Humanos , Neuromielitis Óptica/diagnóstico , Neuromielitis Óptica/epidemiología , Irán/epidemiología , Reproducibilidad de los Resultados , Conjuntos de Datos como Asunto/normas , Femenino , MasculinoRESUMEN
BACKGROUND: The primary objective of this clinical trial was to assess whether administrating oral calcifediol (25(OH)D3) could enhance the clinical outcomes of patients diagnosed with multiple sclerosis. METHODS: This clinical trial was designed as a randomized, double-blind, two-arm study, with 25 participants receiving daily 50 µg of calcifediol and 25 people receiving daily 50 µg of cholecalciferol. The primary outcomes were serum levels of 25(OH)D3, number of relapses, changes in Kurtzke Expanded Disability Status Scale (EDSS), the 25-foot walk, and cognitive function. RESULTS: At the end of the trial, delta serum concentrations of 25(OH)D3 were 85.32±40.94 ng/ml in the calcifediol group compared to 13.72±11.56 ng/ml in the cholecalciferol group; 84 % of the calcifediol group and none of the cholecalciferol group had circulating 25(OH)D3 concentrations exceeding 70 ng/ml. While both groups showed an overall trend towards improved cognitive function at the end of the study, the calcifediol group exhibited greater improvements in most cognitive tests. However, the trial had no significant beneficial effects on MS relapse, EDSS score, quality of life, or fatigue in either group, the calcifediol or cholecalciferol. CONCLUSIONS: The trial shows that calcifediol is more effective in rapidly increasing 25(OH)D3 levels in MS patients compared to cholecalciferol when administrated at a similar dosage.
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Calcifediol , Colecalciferol , Humanos , Calcifediol/sangre , Método Doble Ciego , Femenino , Masculino , Proyectos Piloto , Adulto , Colecalciferol/administración & dosificación , Persona de Mediana Edad , Esclerosis Múltiple/tratamiento farmacológico , Esclerosis Múltiple/sangre , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Esclerosis Múltiple Recurrente-Remitente/sangre , Cognición/efectos de los fármacos , Resultado del TratamientoRESUMEN
INTRODUCTION: Depression and the presence of a disability emerge as noteworthy predictors of the quality of life (QoL) in patients with multiple sclerosis (MS). In this article, we explore the relationship between disability status, depression, and quality of life in individuals with multiple sclerosis. METHODS: A total of 150 patients participated in this cross-sectional study. A Persian translation of the Multiple Sclerosis Quality of Life-54 questionnaire was utilized to assess their health-related quality of life (QoL), while the patients' disability levels were measured using the Expanded Disability Status Scale. Additionally, we assessed patients' depression levels using the 21-item BDI-II scale. The questionnaire data were analyzed using SPSS version 25. RESULTS: A total of 150 MS patients participated in the study, with a mean age of 33.4 years (SD = 3.1). The majority were female (n = 71.2 %). The mean EDSS score was 3.7 (SD = 1.8). In the correlation analysis, we found that EDSS scores were not significantly correlated with mental QoL (r = -0.180, p = 0.109), but were significantly correlated with lower physical QoL (r = -0.393, p 0.001). Depression scores were significantly correlated with mental QoL (r = -0.776, P 0.001) and physical QoL (r = -0. 726, P 0.001). The results reveal that both EDSS and Beck scores significantly affect mental and physical health, explaining 62 % and 60 % of their variances, respectively. CONCLUSION: Our findings indicate a significant relationship between physical quality of life and EDSS scores in MS patients. Higher EDSS scores consistently corresponded to more significant physical impact, as evidenced by higher impact ratings. Conversely, there was no clear association between EDSS scores and mental quality of life. Furthermore, increased depression levels were linked to reduced levels of both mental and physical well-being. These results emphasize the intricate interplay between the physical aspects of quality of life and their implications for the progression and severity of MS in patients.
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Depresión , Esclerosis Múltiple , Calidad de Vida , Humanos , Femenino , Masculino , Adulto , Estudios Transversales , Esclerosis Múltiple/psicología , Esclerosis Múltiple/fisiopatología , Esclerosis Múltiple/complicaciones , Índice de Severidad de la Enfermedad , Evaluación de la Discapacidad , Persona de Mediana EdadRESUMEN
OBJECTIVE: The time to diagnosis of multiple sclerosis (MS) is of great importance for early treatment, thereby reducing the disability and burden of the disease. The purpose of this study was to determine the time from the onset of clinical symptoms to the diagnosis of MS and to evaluate the factors associated with a late diagnosis in Iranian MS patients. METHODS: The present cross-sectional study was conducted on patients with MS who were registered in the National MS Registry System of Iran (NMSRI). RESULTS: Overall, 23291 MS patients registered in 18 provinces of Iran were included in this study. The mean (standard deviation) interval between the onset of the disease and diagnosis of MS was 13.42 (32.40) months, and the median was one month. The diagnostic interval of 41.6% of patients was less than one month, and 14.8% of them had a one-month time to diagnosis. Patients with an age of onset below 18 years and those diagnosed after the age of 50 years had a longer time to diagnosis (P<0.001). Patients with primary progressive MS (PPMS) had the longest time to diagnose and those with relapsing-remitting MS (RRMS) had the shortest time (P<0.001). The results of negative binominal regression showed that the average rate of delay in diagnosis in women was 12% less than that in men. The average delay in diagnosis in patients with a positive family history of MS was 23% more than that in others. The rate of delay in the diagnosis of patients with PPMS and secondary progressive MS was 2.22 and 1.66 times higher, respectively, compared with RRMS. CONCLUSION: The findings of the present study revealed that more than half of the MS patients were diagnosed within a one-month interval from the symptom onset, which is an acceptable period. More attention should be paid to patients' access to medical facilities and MS specialists.
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Esclerosis Múltiple Crónica Progresiva , Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Masculino , Humanos , Femenino , Adolescente , Persona de Mediana Edad , Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple/epidemiología , Esclerosis Múltiple/complicaciones , Estudios Transversales , Irán , Esclerosis Múltiple Crónica Progresiva/diagnóstico , Esclerosis Múltiple Crónica Progresiva/epidemiología , Esclerosis Múltiple Recurrente-Remitente/diagnóstico , Esclerosis Múltiple Recurrente-Remitente/epidemiología , Esclerosis Múltiple Recurrente-Remitente/complicaciones , Sistema de RegistrosRESUMEN
OBJECTIVE: The relationship between MS and ethnicity has been understudied in the Middle East compared to the United States and Europe. As Iran as the highest prevalence of MS in the Middle East, we decided to investigate the demographic and clinical differences in people with MS (pwMS) from major ethnicities Iran. METHODS: In a cross-sectional study using data from National Multiple Sclerosis Registry in Iran. PwMS from six provinces were chosen and interviewed for determining their ethnicity. Persians (Fars), Kurds, Lurs, Azeris and Arabs with a clear ethnic background were included. Recorded data from the registry was used to compare the demographic and clinical features. RESULTS: A total of 4015 pwMS (74.2% female) were included in the study with an average age of 36.76 ± 9.68 years. Persians and Kurds had the highest percentage of pwMS in youngest and oldest age groups, respectively, with 2.9% and 5.7% (p<0.01). The highest average age of onset was seen in Persians (29.47 ± 8.89) and the lowest observed in Mazandaranis (26.82 ± 7.68, p<0.01). Azeris and Kurds had the highest proportions of pwMS diagnosed <18 and >55, at rates of 12% and 1.6%, respectively (p<0.01). There were statistically significant differences in distribution of phenotypes (p<0.01) and time to progression to secondary progressive MS (p<0.01) such that Persians had the highest rate of clinically isolated syndrome (CIS) at 19.3% and Arabs had highest rates of relapsing-remitting MS (86.2%) and secondary progressive MS (16.4%). Lurs, Azeris and Mazandaranis had significantly more patients progressing to secondary-progressive MS <5 years from diagnosis (p<0.01). There was a significant difference in number of relapses between the ethnicities (p<0.01) with Lurs having the highest proportion of participants reporting >4 relapses with 23.0% and Azeris having the highest percentage of pwMS reporting no relapse (53.0%). Kurds had the highest Expanded Disability Status Scale (EDSS) average at 2.93 ± 1.99 and Lurs had the lowest with 1.28 ± 1.25 (p<0.01). The differences in prevalence of positive family history for the whole cohort between ethnicities were significant (P=0.02), ranging from 12.8% in Kurds to 19.6% in Persians. CONCLUSION: We found Persians to have higher rates of pediatric MS and higher rates of CIS. Kurds and Lurs had higher and lower EDSS scores, respectively. Lurs and Persian had higher annual relapse rates. We also found lower rates of SPMS among Arabs and earlier progression to SPMS in Lurs, Azeris and Mazandaranis. Such differences highlight the importance of the potential role of ethnicities in diagnosis and prognosis of MS, especially considering their observation within the geographical limits of a single country.
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Pueblos de Medio Oriente , Esclerosis Múltiple Crónica Progresiva , Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Adulto , Niño , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Transversales , Progresión de la Enfermedad , Irán/epidemiología , Esclerosis Múltiple/epidemiología , Esclerosis Múltiple Crónica Progresiva/epidemiología , Recurrencia Local de Neoplasia , Recurrencia , Sistema de Registros , ÁrabesRESUMEN
BACKGROUND: Among neurological diseases, multiple sclerosis (MS) affects mostly young adults and can cause long-term disability. While most medications with approval from regulatory agencies are very effective in treating MS disease, they are unable to repair the tissue damage found in the central nervous system (CNS). Consequently, Cell-based therapy particularly using mesenchymal stem/stromal cells (MSCs), holds promise for neuroprotection and tissue repair in MS treatment. Furthermore, placenta-derived MSCs (PLMSCs) have shown the potential to treat MS due to their abundance, noninvasive isolation from discarded tissues, no ethical problems, anti-inflammatory, and reparative properties. Accordingly, good manufacturing practices (GMPs) plays a crucial part in clinical SCs manufacturing. The purpose of our article is to discuss GMP-grade PLMSC protocols for treating MS as well as other clinical applications. METHODS AND RESULTS: Placental tissue obtained of a healthy donor during the caesarean delivery and PLMSCs isolated by GMP standards. Flow cytometry was used to assess the expression of the CD markers CD34, CD105, CD90, and CD73 in the MSCs and the mesodermal differentiation ability was evaluated. Furthermore, Genetic evaluation of PLMSCs was done by G-banded karyotyping and revealed no chromosomal instability. In spite of the anatomical origin of the starting material, PLMSCs using this method of culture were maternal in origin. CONCLUSIONS: We hope that our protocol for clinical manufacturing of PLMSCs according to GMP standards will assist researchers in isolating MSCs from placental tissue for clinical and pre-clinical applications.
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Células Madre Mesenquimatosas , Esclerosis Múltiple , Adulto Joven , Humanos , Femenino , Embarazo , Esclerosis Múltiple/terapia , Esclerosis Múltiple/metabolismo , Placenta , Células Madre Mesenquimatosas/metabolismo , Citometría de Flujo , Tratamiento Basado en Trasplante de Células y Tejidos , Células Cultivadas , Diferenciación Celular , Proliferación CelularRESUMEN
Background: The effects of ginseng on fatigue have been proven in patients with multiple sclerosis (MS), which have several similar manifestations to neuromyelitis optica spectrum disorder (NMOSD) patients. This study was designed to evaluate the effects of ginseng on fatigue in NMOSD patients. Methods: In this double-blinded randomized controlled clinical trial, 64 patients were recruited and were allocated into two study groups (ginseng or placebo) via block randomization. The participants received either 250-mg ginseng or placebo twice daily for a 3-month period. Also, the measurement of outcome was performed using the valid and reliable Persian version of fatigue severity scale (FSS) questionnaire, which was filled by patients once after enrollment in the study and once at the end of the study post-intervention. Results: In total, 58 patients finished the study with no major side effects. There were no significant differences in demographic, clinical, as well as FSS between two study groups (p>0.05). Ginseng supplementation significantly reduced fatigue (40.21±13.51 vs. 28.97±14.18; pË0.01), while patients in the placebo group showed significantly higher fatigue score after 3 months post-intervention (35.03±13.51 vs. 38.79±12.27; P: 0.02). The extent of changes in the fatigue score in the ginseng group was significantly greater than in the placebo group (p Ë0.01). Conclusion: This study revealed positive effects of ginseng on reducing fatigue in NMOSD patients with no major side effects. In this regard, further studies are warranted to evaluate and clarify the effects of ginseng on fatigue in NMOSD.
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BACKGROUND: T1 hypointense lesions are considered a surrogate marker of tissue destruction. Although there is a shortage of evidence about T1 hypointense brain lesions, black holes, in patients with Neuromyelitis Optica Spectrum Disorder (NMOSD), the clinical significance of these lesions is not well determined. OBJECTIVES: The impact of T1 hypointense brain lesions on the clinical status and the disability level of patients with NMOSD was sought in this study. METHODS: A total of 83 patients with the final diagnosis of NMOSD were recruited. Aquaporin-4 measures were collected. The expanded disability status scale (EDSS) and MRI studies were also extracted. T1 hypointense and T2/FLAIR hyperintense lesions were investigated. The correlation of MRI findings, AQP-4, and EDSS was assessed. RESULTS: T1 hypointense brain lesions were detected in 22 patients. Mean ± SD EDSS was 3.7 ± 1.5 and significantly higher in patients with brain T1 hypointense lesions than those without them (p-value = 0.01). Noticeably, patients with more than four T1 hypointense lesions had EDSS scores ≥ 4. The presence of T2/FLAIR hyperintense brain lesions correlated with EDSS (3.6 ± 1.6 vs 2.3 ± 1.7; p-value = 0.01). EDSS was similar between those with and without positive AQP-4 (2.7 ± 1.6 vs. 3.2 ± 1.7; p-value = 0.17). Also, positive AQP-4 was not more prevalent in patients with T1 hypointense brain lesions than those without them (50.9 vs 45.4%; p-value = 0.8). CONCLUSION: We demonstrated that the presence of the brain T1-hypointense lesions corresponds to a higher disability level in NMOSD.
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Esclerosis Múltiple , Neuromielitis Óptica , Humanos , Neuromielitis Óptica/diagnóstico por imagen , Neuromielitis Óptica/patología , Estudios Transversales , Esclerosis Múltiple/patología , Imagen por Resonancia Magnética , Acuaporina 4 , Encéfalo/diagnóstico por imagen , Encéfalo/patología , Estudios RetrospectivosRESUMEN
The prevalence of cognitive impairment in multiple sclerosis (MS) patients is estimated to be approximately 40-60%. There is an increasing body of evidence regarding the impact of both selenium and crocin as antioxidant agents on cognitive function. In the present study, for the first time, we investigated the effect of crocin-selenium nanoparticles (Cor@SeNs) on cognitive function and oxidative stress markers in MS patients. A triple-blind randomized clinical trial was conducted among 60 MS patients. The participants were randomly divided in a 1:1 ratio to either the Cor@SeNs or placebo group, employing block randomization. During the course of 12 weeks, the participants received Cor@SeNs capsules, containing 5.74 mg crocin and 55 mcg Selenium, or placebo capsules. Cognition assessed using the Persian version of the Brief International Cognitive Assessment for MS (BICAMS) battery. Serum levels of total antioxidant capacity (TAC), glutathione reductase (GR) activity and malondialdehyde (MDA) determined by colorimetric kits. Data analysis was performed in SPSS, version 26. P < 0.05 was considered as the significant range. The mean ± SD of TAC change was 0.03 ± 0.07 mM vs. - 0.03 ± 0.09 mM in intervention and placebo groups, respectively (Time × group effect P: 0.01; effect size: 0.10). The time effect of intervention on the California Verbal Learning Test second edition (CVLT-II) (P < 0.01; effect size: 0.29), CVLT-II-delay (P < 0.01; effect size: 0.29), and the Symbol Digit Modalities Test (SDMT) (P < 0.01; effect size: 0.18) was increasing and significant. In addition, the time effect of intervention on GR activity was significant and decreasing in both groups (P < 0.01; effect size: 0.20). Our results suggested a significant effect of the Cor@SeNs intervention in improving TAC. We also observed a significant improvement in cognitive function in both groups during our study. However, although not statistically significant, a higher amount of change in cognitive function and serum antioxidant markers was noted in the Cor@SeNs group compared to the placebo group. This is the first study on this nano product with low dose of selenium and crocin. More investigations with longer duration and varied doses are suggested.
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Carotenoides , Esclerosis Múltiple , Selenio , Humanos , Esclerosis Múltiple/tratamiento farmacológico , Selenio/farmacología , Selenio/uso terapéutico , Antioxidantes , Cognición , Estrés Oxidativo , BiomarcadoresRESUMEN
OBJECTIVES: To measure the health spillover effect in caregivers of patients with multiple sclerosis (MS), we aimed to select the best instrument from 2 common health-related quality of life (QoL) instruments, the 3-level EQ-5D (EQ-5D-3L) and the Health Utilities Index Mark 3 (HUI-3), by assessing them. METHODS: Using consecutive sampling, 452 primary caregivers of patients with MS were asked to fill out a Care-related QoL instrument (CarerQol-7D), EQ-5D-3L, HUI-3, and the Center for Epidemiologic Studies Depression Scale between October 2019 and May 2020. Convergent and clinical validity were assessed to measure spillover effect in caregivers of patients with MS. RESULTS: A strong correlation of health-utility scores between EQ-5D-3L and HUI-3 (r = 0.914, P < .01) was observed. The 95% limit of agreement (LoA) for CarerQol-7D and HUI-3 (-10.6 to 8.2) was narrower than the LoA for CarerQol-7D and EQ-5D-3L (-15.1 to 17.1). Both EQ-5D-3L and HUI-3 proved clinical validity for the QoL of caregivers. The CarerQoL-7D score was significantly lower in female (P < .001), single (P < .014), lower-educated (P < .001), parent's relatives (P < .001), and unemployed (P < .001) caregivers. CONCLUSIONS: We found that both, EQ-5D-3L and HUI-3, were appropriate for measuring caregivers' QoL, although HUI-3 was a better choice because of its narrower LoA. Our findings suggest researchers should use HUI-3 to measure the quality-adjusted life-year of caregivers to aggregate with the QoL of patients in the denominator of an economic evaluation equation, such as the cost-effective ratio.
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Esclerosis Múltiple , Calidad de Vida , Humanos , Femenino , Cuidadores , Esclerosis Múltiple/terapia , Encuestas y Cuestionarios , Reproducibilidad de los ResultadosRESUMEN
Background: It seems that patients with multiple sclerosis (MS) are at a higher risk for coronavirus disease 2019 (COVID-19) implications due to being subjected to immunomodulatory or immunosuppressive treatments. Besides, obesity as a risk factor may lead to more adverse consequences. The relationship between obesity and COVID-19 morbidity and outcomes in Iranian patients with MS still remains unclear. Methods: A cross-sectional study was conducted in Sina Hospital, Tehran, Iran. Patients with MS were asked to complete an online questionnaire in the Google Form format. Demographic information, clinical information including MS disease-related factors, COVID-19-related factors, and anthropometric information were recorded. Totally, 492 patients filled the questionnaire during two weeks in November 2021, by the response rate of 21.6%. Body mass index (BMI) was categorized based on the standard classification of the World Health Organization (WHO). The logistic regression was used to examine the risk of morbidity and chi-square test/one-way analysis of variance (ANOVA) was employed to determine the difference regarding severity and symptoms among groups. Results: In the fully adjusted model, the odds ratio (OR) of COVID-19 morbidity in class II obese participants was significantly 5.41 times higher than that in the normal BMI group [OR: 5.41, 95% confidence interval (CI): 1.00-29.09]. COVID-19 severity was significantly different among BMI groups (P = 0.024). Respiratory symptoms (P = 0.05) as well as gastrointestinal (GI) symptoms (P < 0.01) of COVID-19 were more prevalent among class I and class II obese patients compared with overweight, normal weight, and underweight groups. Moreover, no one in the class I and class II obesity groups reported COVID-19 morbidity without any symptoms (P = 0.04). Conclusion: The results of the current study support the view that obesity could play a key role in susceptibility to COVID-19 morbidity and severity of the symptoms in patients with MS. The findings recommended that neurologists pay more attention to patients' BMI during this pandemic.
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Background: Multiple sclerosis (MS) is a debilitating, non-traumatic, neurological disorder in young adults and can reduce quality of life (QoL) by interfering with the ability to work, leisure activities, and routine living tasks. Various studies have shown the dissatisfaction of people with MS in different areas of care services. Regarding the patients' weakness with care and services, we sought to identify the challenges for patients with MS in receiving care and services in Iran. Methods: This cross-sectional study was conducted in 2016-2018 using a researcher-made questionnaire (designed by MS Specialists in an MS research center). The questionnaire examined the care challenges in four areas: 1) costs of medication, hospitalization, and rehabilitation services, 2) family support, insurance system, and job protection, 3) access to transportation system and treatment team, 4) quality of the provided care and services. Results: Completed questionnaires were received from 945 respondents. The mean age of responders was 35.92 years. In total, 731 (77.8) participants were women and 208 (22.2) were men. Academic education was reported among 615 (65.3) participants and 367 (40.2) were employed during the study, while 99 (10.5) of the subjects were not able to walk a minimum of 20 meters. The prioritization of care services challenges was as follows: the cost of pharmaceutical services (49.1), lack of telephone counseling (47.4), uninsured home rehabilitation (44.7), lack of qualified care centers (41.2), and rehabilitation costs (40.2). Conclusion: We found that patients who could not walk at least 20 meters and unemployed individuals had more problems and lower QoL. The patients who had non-academic education had more challenges with the cost of medication, transportation, and lack of familial support. This study shows the challenges of MS patients in receiving health care in Iran that vary in age, education, employment, and ability to walk. As the abovementioned challenges are of great importance in determining the QoL of people with MS, an appropriate solution is provided in this study to overcome these challenges.
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Background: This study was conducted to evaluate the relationship between retinal layer thickness (RLT) and cognition in patients with multiple sclerosis (MS). Methods: We searched PubMed, Scopus, Embase, Web of Science, and Google Scholar. The search strategy included the MeSH and text words as ["ora serrata" OR "retina" OR ("coherence tomography" AND "optical") OR "OCT tomography" OR (tomography AND OCT) OR "optical coherence tomography" OR "OCT" OR "retinal thickness" OR "inner plexiform layer" OR "nerve fiber layer" OR "ganglion cell layer" OR "inner nuclear layer" OR "outer plexiform layer" OR "outer nuclear layer" OR "external limiting membrane" OR "inner segment layer" OR "outer segment layer" OR "retinal pigment epithelium"] AND ["cognition"* OR "cognitive function"* OR (function* AND cognitive)] AND [(sclerosis AND multiple) OR (sclerosis AND disseminated) OR "disseminated sclerosis" OR "multiple sclerosis" OR "acute fulminating"]. Results: The literature search revealed 1090 articles; after deleting duplicates, 980 remained. Finally, 14 studies were included. Totally, 1081 patients were evaluated. Mean age ranged from 31 to 55 years. In some studies, there was a correlation between cognition and retinal thickness, while others did not confirm this finding. Some authors found cognitive impairment (CI) in patients with MS with RLT. Conclusion: The results of this systematic review show that there are discrepancies between the results of studies regarding the relationship between RLT and cognition status in patients with MS. Further studies with more included original studies and meta-analysis are recommended.
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Background: People with multiple sclerosis (MS) and their physicians recognize cognitive retention as an important desired outcome of disease-modifying therapies (DMTs). In this study, we attempted to gather the opinions of Iranian MS experts regarding the treatment approach toward clinical cases with different physical and cognitive conditions. Methods: Opinions of 20 MS specialists regarding the best approach to 6 case scenarios (with different clinical, cognitive, and imaging characteristics) were gathered via a form. Results: The estimated kappa of 0.16 [95% confidence interval (CI): 0.159-0.163; P < 0.001] suggested a poor degree of agreement on the treatment choice among the professionals. Conclusion: Although most specialists agreed with treatment escalation in cases with cognitive impairment, there was no general agreement. Furthermore, there was not enough clinical evidence in the literature to develop consensus guidelines on the matter.
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Background: Fingolimod is approved in relapsing-remitting multiple sclerosis (RRMS) with the recommended dose of 0.5 mg daily. To tackle possible adverse events, some clinicians may reduce the dose of fingolimod, mainly in the alternate-day form. We systematically reviewed the literature for efficacy measures of this method. Methods: PubMed (Medline®), Web of Science, Embase, Scopus, and the Cochrane Library databases were searched until April 9, 2021. Clinical studies (other than case reports and case series), in English, were included. Then, publications concerning alternate dose fingolimod (including every other day, every two or three days) were selected. Those studies concerning reduced daily dose (any daily dose less than 0.5 mg/day) were excluded to focus on alternate dosing. Results: Four observational studies were included. Data on Ohtani et al. study were limited. Three other studies were of good quality based on the Newcastle-Ottawa Scale. A total of 296 patients on the standard dose were compared to 276 patients on the alternate dosage. The most common reason for switching to the alternate dose was lymphopenia, followed by elevated liver enzymes. Two studies concluded that the alternate dosing could be a safe, yet effective strategy in patients with intolerable adverse effects of daily dose. However, Zecca et al. warned about the high possibility of disease reactivation. Due to the differences in outcome measures of the studies, meta-analysis was not applicable. Conclusion: This systematic review highlights the ambiguity of evidence on safety and efficacy of alternate dosing of fingolimod, encouraging further research on the subject.