BackgroundThere are no determined treatment agents for the severe coronavirus disease 2019 (COVID-19); therefore, it is suggested that methylprednisolone, as an immunosuppressive treatment, can reduce the inflammation of the respiratory system.MethodsWe conducted a single-blind, randomised, controlled, clinical trial involving severe hospitalised patients with confirmed COVID-19 at the early pulmonary phase of the illness in Iran. The patients were randomly allocated in a 1:1 ratio by block randomisation method to receive standard care with methylprednisolone pulse (intravenous injection, 250 mg·day−1 for 3 days) or standard care alone. The study endpoint was the time of clinical improvement or death, whichever came first. Primary and safety analysis was done in the intention-to-treat (ITT) population.ResultsSixty-eight eligible patients underwent randomisation (34 patients in each group) from April 20, till Jun 20, 2020. In the standard care group, six patients received corticosteroids by the attending physician during treatment and excluded from the ITT population. Patients with clinical improvement were higher in the methylprednisolone group than in the standard care group (94·1% versus 57·1%), and the mortality rate was numerically lower in the methylprednisolone group (5·9% versus 42.9%; p <0·001). We demonstrated that patients in the methylprednisolone intervention group had a significantly increased survival time compared with the patients in the standard care group [Log rank test: p<0.001; Hazard ratio: 0.293; 95% CI: 0.154–0.556]. A total of two patients in each group (5·8% and 7·1% respectively) showed severe adverse events between initiation of treatment and the end of the study.ConclusionsOur results suggested that methylprednisolone pulse could be an efficient therapeutic agent for hospitalised severe COVID-19 patients at the pulmonary phase.
There is limited evidence that ginger (生薑 shēng jiāng) powder consumption can relieve pain and inflammation because of its special phytochemical properties. This study is aimed at investigating the effect of ginger powder supplementation on some inflammatory markers in patients suffering from knee osteoarthritis. This is a double-blind randomized placebo-controlled clinical trial with a follow-up period of 3 months that was conducted on 120 outpatients with moderately painful knee osteoarthritis. Patients were randomly divided up into two groups: ginger group (GG) or placebo group (PG). Both groups received two identical capsules on a daily basis for 3 months. Each ginger capsule contained 500 mg of ginger powder; the placebo capsules had 500 mg of starch in them. Serum samples were collected prior to and after the intervention and were stored at −70 °C until the end of the study. Serum concentration of nitric oxide (NO) and hs-C reactive protein (hs-CRP) were measured using enzyme-linked immunosorbent assay kits. There was no significant difference between the two groups in terms of inflammatory markers (i.e., NO and hs-CRP) prior to the intervention. However, after 3 months of supplementation, serum concentration of NO and hs-CRP decreased in the GG. After 12 weeks, the concentration of these markers declined more in the GG than in the PG. Ginger powder supplementation at a dose of 1 g/d can reduce inflammatory markers in patients with knee osteoarthritis, and it thus can be recommended as a suitable supplement for these patients.
There is limited evidence that ginger powder consumption can relieve pain and inflammation due to specific anti-inflammatory phytochemical constitutents. This study investigates the effect of ginger supplementation on proinflammatory factors in participants (n = 120) of a randomized double-blind placebo-controlled 3-month clinical trial investigating knee osteoarthritis. Patients were randomly assigned to one of two groups: the ginger group (GG) or the placebo group (PG). Administered daily for 3 months, participants in the GG intervention received capsules containing 500 mg of ginger powder, while PG participants received capsules filled with 500 mg starch. Serum samples collected at baseline and 3 months were analyzed for serum levels of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β). At baseline, proinflammatory cytokine concentrations did not differ by group. However, at 3 months, both cytokines decreased in the GG relative to the PG. The results of this study indicate that ginger supplementation may have a promising benefits for knee osteoarthritis and may, therefore, may warrant further study.
The COVID-19 is rapidly scattering worldwide, and the number of cases in the Eastern Mediterranean Region is rising. Thus, there is a need for immediate targeted actions. We designed a longitudinal study in a hot outbreak zone to analyze the serial findings between infected patients for detecting temporal changes from February 2020. In a hospital-based open-cohort study, patients are followed from admission until one year from their discharge (the 1st, 4th, 12th weeks, and the first year). The patient recruitment phase finished at the end of August 2020, and the follow-up continues by the end of August 2021. The measurements included demographic, socio-economics, symptoms, health service diagnosis and treatment, contact history, and psychological variables. The signs improvement, death, length of stay in hospital were considered primary, and impaired pulmonary function and psychotic disorders were considered main secondary outcomes. Moreover, clinical symptoms and respiratory functions are being determined in such follow-ups. Among the first 600 COVID-19 cases, 490 patients with complete information (39% female; the average age of 57±15 years) were analyzed. Seven percent of these patients died. The three main leading causes of admission were: fever (77%), dry cough (73%), and fatigue (69%). The most prevalent comorbidities between COVID-19 patients were hypertension (35%), diabetes (28%), and ischemic heart disease (14%). The percentage of primary composite endpoints (PCEP), defined as death, the use of mechanical ventilation, or admission to an intensive care unit was 18%. The Cox Proportional-Hazards Model for PCEP indicated the following significant risk factors: Oxygen saturation < 80% (HR = 6.3; [CI 95%: 2.5,15.5]), lymphopenia (HR = 3.5; [CI 95%: 2.2,5.5]), Oxygen saturation 80%-90% (HR = 2.5; [CI 95%: 1.1,5.8]), and thrombocytopenia (HR = 1.6; [CI 95%: 1.1,2.5]). This long-term prospective Cohort may support healthcare professionals in the management of resources following this pandemic.
The aim of the study was to evaluate the effects of administration of 25-hydroxyvitamin D [25(OH) D] on serum antimullerian hormone (AMH) levels in infertile women. The study was performed as a non-randomized clinical trial on 30 infertile women who had low serum level of both 25(OH) D and anti-mullerian hormone. Vitamin D was prescribed 50,000 IU weekly for up to three months for all eligible participants. Serum levels of both 25(OH) D and AMH have increased significantly after treatment with 25(OH) D. There was a significant correlation between serum levels of 25(OH) D after treatment with AMH (p = .029, OR = 2.9, CI 95% = 2.7-5.5). Mean AMH level after treatment was higher in women with sufficient 25(OH) D, than women with insufficient 25(OH) D (1.048 ± 0.644 vs. 0.513 ± 0.284 ng/ml), which shows a significant difference (p = .043). Also, after treatment, in women with mean AMH level of >0.7 ng/ml (19 women), mean level of 25(OH) D was higher than in women with mean AMH level of <0.7 ng/ml (11 women) (59.332 ± 21.751 vs. 38.881 ± 17.281 ng/ml, p = .013). This means that higher levels of 25(OH) D are accompanied with higher levels of AMH. In conclusions with administration and increasing the amount of vitamin D serum levels, the serum levels of AMH have increased.
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