Background Magnesium supplements are widely used for prophylaxis and treatment of nocturnal leg cramps (NLC). However, there is little evidence in support of their effectiveness. The main impediment stems from the lack of assessments of cellular absorption. In the current study, we tested the efficacy and safety of a magnesium supplement – magnesium oxide monohydrate (MOMH), for which increased cellular absorption rates were demonstrated in an ex-vivo setting. Methods A randomized, double-blind, placebo-controlled multicenter study was conducted in hospitals and outpatient clinics in Ukraine, from February to August 2018. Eligible subjects received a capsule with MOMH 226 mg or placebo, once daily, at bedtime, for a 60-day period. The assessed parameters included frequency and duration of NLC episodes, quality of sleep, NLC-induced pain and quality of life sub-scores. The Fisher’s Exact Test for comparison of groups by categorical variables was used. The Student’s test or Mann-Whitney test were used for between-group comparison at different timepoints. ANCOVA followed by contrast analysis was used for comparison of groups at the end of the study. Results 175 (81%) out of 216 initially screened subjects completed the study. The number of NLC episodes has significantly decreased by the end of the study period as compared to baseline in both groups (p < 0.001 for both). There was a significant between-group difference in the magnitude of reduction in NLC episodes (p = 0.01), indicating a higher decrease in the MOMH group as compared to the placebo group (− 3.4 vs − 2.6, respectively). In addition, MOMH treatment resulted in a greater reduction in NLC duration (p < 0.007) and greater improvement in sleep quality (p < 0.001) as compared to placebo. Conclusions MOMH was shown to be effective in the treatment of NLC as well as safe and well-tolerated. Trial registration NCT03807219, retrospectively registered on January 16, 2019.
The purpose of the study: the study of clinical efficacy and safety of the Neuromidin® in the rehabilitation period in patients with primary ischemic stroke, its eff ect on motor, cognitive function, level of household adaptation, depending on the presence or absence of neglekt syndrome and "push-syndrome". 60 patients aged 49 to 82 years in the recovery period of ischemic stroke were examined (30 patients — the main group: treatment with the addition of Neuromidin®; 30 patients — control group: standard treatment without adding Neuromidin®). Investigation of motor, cognitive, and sensitive disorders was carried out with the use of clinical scales. The effectiveness of the treatment was evaluated in the absence of signs of neglekt syndrome and "push-syndrome", reduction of motor and cognitive impairment. Patients with neglekt syndrome showed greater dependence on third-party care and more severe cognitive impairment than in patients who had not been diagnosed neglekt syndrome. After treatment, the majori ty of patients achieved elimination of neglekt syndrome, but in the group where patients received Neuromidin®, the number of such patients was higher. In addition, patients in the main group improved cognitive function. The use of Neuromidin® in complex rehabilitation measures in patients with ischemic stroke contributes to the restoration of lost functions, reduces the phenomena of visual-spatial neglect, positively affects self-care and improves the quality of life of patients and their relatives.
Хвороба Паркінсона (ХП) -хронічне повільно прогресуюче нейродегенеративне захворювання, яке характеризується патологічним пошкодженням дофамінергічних (ДА) нейронів, формуванням внутрішньоплазматичних включень, відомих як тільця Леві. Етіологія ХП до кінця невідома, різні фактори, включаючи генетичні, імунологічні, екологічні, ініціюють нейродегенеративний процес ДА-нейронів. Результати ряду клінічних досліджень показують можливу роль імунної системи, зокрема аутоімунних механізмів, в етіопатогенезі ХП. Близько 30 років пройшло з того періоду, коли вперше було виявлено активовану мікроглію головного мозку на аутопсії у пацієнтів із ХП. З тих пір науковці намагаються дослідити вплив запального процесу на розвиток та прогресування дегенерації ДА-нейронів. Мета дослідження. Вивчити концентрацію протизапального (ІЛ-10) та прозапальних цитокінів (ІЛ-1β, ІЛ-6) у пацієнтів із ХП та аутоімунним тиреоїдитом (АІТ), оцінити їх зв'язок із моторними та немоторними порушеннями. Матеріали та методи дослідження. Обстежено 109 пацієнтів із ХП віком від 47 до 75 років (середній вік 61,0±14,0). Основну групу склали пацієнти ІА та ІБ підгрупи, контрольну -ІІА та ІІБ підгрупи. Проведені загальноклінічне та неврологічне обстеження, оцінка рухових функцій за Уніфікованою шкалою оцінки ХП (UPDRS), нейропсихологічне тестування (MoCA, FAB, шкала депресії Бека (BDI), шкала тривоги Гамільтона (HARS)), використано шкалу для оцінки вегетативних порушень у пацієнтів із ХП. Концентрацію цитокінів в сироватці крові визначали методом твердофазного імуноферментного аналізу за допомогою наборів реагентів фірми "Вектор Бест". Статистичний аналіз за допомогою програми «Statistica 6.0». Результати. Проведене дослідження показало статистично значуще підвищення рівня прозапальних цитокінів (ІЛ-1β, ІЛ-6) в сироватці крові у пацієнтів із ХП та АІТ у порівнянні із хворими на ХП. Рівень протизапального цитокіну ІЛ-10 у пацієнтів ІА підгрупи був статистично значущо вищий в порівнянні із хворими ІІА підгрупи. Нами не було виявлено статистично значущої різниці між показники концентрації ІЛ-10 в сироватці крові в осіб ІБ та ІІБ підгруп. Встановлено зв'язок на статистично значущому рівні між показниками цитокінового профілю та даними нейропсихологічного тестування, загальним показником шкали оцінки вегетативних порушень у пацієнтів із ХП, вихідним балом шкали UPDRS. Висновки. Пацієнти з ХП та АІТ мали вищі показники інтерлейкінів (ІЛ-1β, ІЛ-6, ІЛ-10) в сироватці крові в порівнянні з контрольною групою (хворі на ХП). Спостерігався зв'язок на статистично значущому рівні між показниками цитокінового профілю та моторними і немоторними проявами ХП Ключові слова: хвороба Паркінсона, аутоімунний тиреоїдит, інтерлейкіни, нейропсихологічне тестування, моторні порушення Рекомендовано до публікації д-р мед. наук Насонова Т. І. Дата надходження рукопису 12.06.2018 Тетяна Олександрівна Чеборака, аспірант, кафедра неврології № 1, Національна медична академія післядипломної освіти імені П. Л. Шупика, вул. Дорогожицька,
Parkinson's disease (PD) is a progressive neurodegenerative disease characterized by the predominantly dopaminergic neuronal black matter degeneration. The multicentre study of PRIAMO (PaRkinson & non Motor symptom) showed that in 98.6 % of cases, non-motor symptoms (NMS) were observed in patients with PD. Cognitive impairment is one of the most common NMS PD. According to these studies, cognitive dysfunction develops in most patients at an early stage of the disease, with mild to moderate cognitive impairment. In the later stages of the disease, dementia occurs in 80 % of patients with PD. Aim of the research. To study the peculiarities of cognitive impairment in patients with PD and autoimmune thyroiditis (AIT), their association with motor and non-motor disorders, and to assess the impact on the quality of life of patients. Materials and methods of the research. 109 patients with PD aged 47 to 75 years were examined. The main group consisted of patients with IA and IB subgroups, control – IIA and IIB subgroups. General clinical and neurological examinations, evaluation of motor functions by the Unified Parkinson's disease Rating Scale (UPDRS), neuropsychological testing (MMSE, MoCA, FAB, BDI), Hamilton's Alert Scale (HARS), scale used for assessing autonomic disorders in patients with PD and Parkinson’s disease questionnaire (PDQ-39), statistical analysis using the "Statistica 6.0" program. Results. Neuropsychological testing showed that MMSE, MoCA, and FAB obtained from patients with PD and AIT are lower compared to patients with PD. Analyzing the indicators of MMSE, FAB, and MoCA scales in dynamics, a statistically significant difference was found in subgroups of IB and IIB; in subgroups of IA and IIA – was not observed. During the analysis of the results of the neuropsychological testing, no association was found at the statistically significant level in the subgroups of IA and IB between the duration of the disease and MMSE, MoCA, and FAB scales. In the IA subgroup, in the initial review, feedback was observed on a statistically significant level of average strength between the level of anxiety and the indicator of the MMSE scale, an indicator of the MoCA scale. In the IA subgroup, there was no relationship at the statistically significant level between the indicators of neuropsychological testing (MMSE, MoCA, FAB) and motor and non-motor manifestations (depression, vegetative disorders). There was a connection at a statistically significant level between the indicators of neuropsychological testing (MMSE, MoCA, FAB) and motor and non-motor manifestations of PD in patients who received anti-parkinsonian therapy for a long period of time. The negative influence of the level of cognitive impairments on the quality of life of patients with PD and AIT was revealed, indicating the high medical and social significance of these violations. Conclusions. Neuropsychological testing showed that MMSE, MoCA, FAB scores in patients with PD and AIT (IB subgroup) were lower compared to patients with PD (IIB subgroup). There was a connection at a statistically significant level between the indicators of neuropsychological testing (MMSE, MoCA, FAB) and motor and non-motor manifestations of PD in patients who received anti-parkinsonian therapy for a long period of time. The negative influence of the level of cognitive impairments on the quality of life of patients with PD and AIT was revealed, indicating the high medical and social significance of these violations.
Background: Magnesium supplements are widely used for prophylaxis and treatment of nocturnal leg cramps (NLC). However, there is little evidence in support of their effectiveness. The main impediment stems from the lack of assessments of cellular absorption. In the current study, we tested the efficacy and safety of a magnesium supplement – magnesium oxide monohydrate (MOMH), for which increased cellular absorption rates were demonstrated in an ex-vivo setting. Methods: A randomized, double-blind, placebo-controlled multicenter study was conducted in hospitals and outpatient clinics in Ukraine, from February to August 2018. Eligible subjects received a capsule with MOMH 226mg or placebo, once daily, at bedtime, for a 60‑day period. The assessed parameters included frequency and duration of NLC episodes, quality of sleep, NLC-induced pain and quality of life sub-scores. The Fisher's Exact Test for comparison of groups by categorical variables was used. The Student’s test or Mann-Whitney test were used for between-group comparison at different timepoints. ANCOVA followed by contrast analysis was used for comparison of groups at the end of the study. Results: 175 (81%) out of 216 initially screened subjects completed the study. The number of NLC episodes has significantly decreased by the end of the study period as compared to baseline in both groups (p<0.001 for both). There was a significant between-group difference in the magnitude of reduction in NLC episodes (p=0.01), indicating a higher decrease in the MOMH group as compared to the placebo group (-3.4 vs -2.6, respectively). In addition, MOMH treatment resulted in a greater reduction in NLC duration (p<0.007) and greater improvement in sleep quality (p<0.001) as compared to placebo.Conclusions: MOMH was shown to be effective in the treatment of NLC as well as safe and well-tolerated. ClinicalTrials.gov identification number: NCT03807219, retrospectively registered on January 16, 2019.
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