This trial aims to evaluate the effectiveness of adding melatonin to the treatment protocol of hospitalized coronavirus disease 2019 (COVID‐19) patients. This was an open‐label, randomized controlled ...clinical trial in hospitalized COVID‐19 patients. Patients were randomized into a treatment arm receiving melatonin plus standard care or a control arm receiving standard care alone. The trial's primary endpoint was sleep quality examined by the Leeds Sleep Evaluation Questionnaire (LSEQ). The trial's secondary endpoints were symptoms alleviation by Day 7, intensive care unit admission, 10‐day mortality, white blood cell count, lymphocyte count, C‐reactive protein status, and peripheral capillary oxygen saturation. Ninety‐six patients were recruited and allocated to either the melatonin arm (n = 48) or control arm (n = 48). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms on Day 7. The mean of the LSEQ scores was significantly higher in the melatonin group (p < 0.001). There was no significant difference in laboratory data, except for blood oxygen saturation, which has improved significantly in the melatonin group compared with the control group (95.81% vs. 93.65% respectively, p = 0.003). This clinical trial study showed that the combination of oral melatonin tablets and standard treatment could substantially improve sleep quality and blood oxygen saturation in hospitalized COVID‐19 patients.
Highlights
Melatonin can provide significant improvement in COVID‐19 patients' sleep quality.
Melatonin can be helpful for increasing blood oxygen saturation in COVID‐19 patients in combination with the standard treatment.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Background
The aim of this clinical trial was to evaluate the effects of febuxostat (FBX) in comparison with hydroxychloroquine (HCQ) on clinical symptoms, laboratory tests and chest CT findings in ...outpatients with moderate symptoms of COVID‐19 infection.
Methods
We conducted a clinical trial involving adult outpatients with the moderate respiratory illness following COVID‐19 infection. Patients were randomly assigned to receive either FBX or HCQ for 5 days. The measured variables were needs to hospitalisation, clinical and laboratory data including fever, cough, breathing rate, C‐Reactive Protein level, lymphocytes count at onset of admission and was well as at 5 days of treatments. In addition, CT findings were evaluated on admission and 14 days after initiation of treatment.
Results
Sixty subjects were enrolled in the study with a 1 to 1 ratio in FBX and HCQ groups. On admission, fever (66.7%), cough (87%), tachypnoea (44.4%), dyspnoea (35%), elevated CRP value (94.4%) and lung involvement according to chest CT (100%) were documented in enrolled patients with insignificant difference between FBX and HCQ groups. Fever, cough and tachypnoea were significantly mitigated in both groups after five days of treatments without any significant differences between groups. The mean percentages of lung involvement were significantly reduced to 7.3% and 8% after 14 days of treatment with FBX and HCQ, respectively. In adult outpatients with moderate COVID‐19 infection, the effectiveness of FBX and HCQ was not different in terms of resolution of clinical manifestations, laboratory tests and lung CT findings.
Conclusion
This trial suggests that FBX is as an alternative treatment to HCQ for COVID‐19 infection and may be considered in patients with a contraindication or precaution to HCQ.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Background
Evidence recommends that vitamin D might be a crucial supportive agent for the immune system, mainly in cytokine response regulation against COVID‐19. Hence, we carried out a systematic ...review and meta‐analysis in order to maximise the use of everything that exists about the role of vitamin D in the COVID‐19.
Methods
A systematic search was performed in PubMed, Scopus, Embase and Web of Science up to December 18, 2020. Studies focused on the role of vitamin D in confirmed COVID‐19 patients were entered into the systematic review.
Results
Twenty‐three studies containing 11 901 participants entered into the meta‐analysis. The meta‐analysis indicated that 41% of COVID‐19 patients were suffering from vitamin D deficiency (95% CI, 29%‐55%), and in 42% of patients, levels of vitamin D were insufficient (95% CI, 24%‐63%). The serum 25‐hydroxyvitamin D concentration was 20.3 ng/mL among all COVID‐19 patients (95% CI, 12.1‐19.8). The odds of getting infected with SARS‐CoV‐2 are 3.3 times higher among individuals with vitamin D deficiency (95% CI, 2.5‐4.3). The chance of developing severe COVID‐19 is about five times higher in patients with vitamin D deficiency (OR: 5.1, 95% CI, 2.6‐10.3). There is no significant association between vitamin D status and higher mortality rates (OR: 1.6, 95% CI, 0.5‐4.4).
Conclusion
This study found that most of the COVID‐19 patients were suffering from vitamin D deficiency/insufficiency. Also, there is about three times higher chance of getting infected with SARS‐CoV‐2 among vitamin‐D‐deficient individuals and about five times higher probability of developing the severe disease in vitamin‐D‐deficient patients. Vitamin D deficiency showed no significant association with mortality rates in this population.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Abstract
The Sputnik V is a COVID- 19 vaccine developed by the Gamalia institute of epidemiology and microbiology and released on August 11, 2020. We provided independent evidence on side effects and ...immunogenicity following the administration of the Sputnik V COVID-19 in Iran. In this observational study, the healthcare workers who were vaccinated with the Sputnik V COVID-19 vaccine within February and April 2021 were evaluated. Among a total of 13,435 vaccinated healthcare workers, we received 3236 self-declaration reports of Sputnik V associated adverse events with the mean age 39.32 ± 10.19 years old which 38.8% were men and 61.2% were women. Totally 68.8% of females versus 66.2% of males reported side effects after receiving the first dose and 31.2% of females versus 33.8% of males reported side effects after the second dose of vaccine. The most common side effect was a pain in the injection site (56.9%), fatigue (50.9%), body pain (43.9%), headache (35.7%), fever (32.9%), joint pain (30.3%), chilling (29.8%) and drowsiness (20.3%). Side effects of the vaccine were significantly more frequent in females and younger individuals. Among a total of 238 participants, more than 90% after the first and second dose of vaccine had a detectable level of SARS-CoV-2 RBD antibody and SARS-CoV-2 neutralizing antibody. Although the overall rate of adverse effects was higher than the interim results from randomized controlled trials, our findings support the manufacturer’s reports about the high humoral immunogenicity of vaccine against COVID-19.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Idiopathic granulomatous mastitis (IGM) is an inflammatory disease of the breasts with an unknown etiology. Corticosteroids are one the primary options for treating this disease, but the results of ...previous studies concerning their efficacy have been controversial. We, therefore, decided to assess the effectiveness of corticosteroids on IGM using a systematic review and meta-analysis. We conducted a systematic search using MeSH terms and all relevant keywords in PubMed, EMBASE, Cochrane Library and Web of Science until May 21, 2019. Data were analyzed using the Comprehensive Meta-Analysis (CMA) V.2 software program and presented as the event rate, risk ratio (RR) and risk difference (RD). Twelve studies including 559 IGM patients were entered into the meta-analysis. Our analysis showed that the RR and RD of recurrence in the steroid-only group compared with the surgery-only group were 2.99 (95% confidence interval CI 0.28–31.33) and 0.14 (95% CI − 0.01–0.30), respectively, showing no statistical significance. The meta-analysis of the steroid-only group and steroid + surgery group showed that the RR of recurrence was 6.13 (95% CI 0.41–81.62) with no significance. However, the meta-analysis of the RD showed that the risk of recurrence in the steroid group was significantly higher than that in the steroids + surgery group (RD: 0.28, 95% CI 0.11–0.44). This meta-analysis showed that managing IGM with only steroids may be less effective than the combination of steroids and surgery. This combination approach may result in a lower rate of recurrence and side effects in these patients.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Background. Despite the importance of identifying proper novel porcelain preparation techniques to improve bonding of orthodontic brackets to porcelain surfaces, and despite the highly controversial ...results on this subject, no systematic review or meta-analysis exists in this regard. Objective. To comparatively summarize the effects of all the available porcelain surface treatments on the shear bond strength (SBS) and adhesive remnant index (ARI) of orthodontic brackets (metal, ceramic, polycarbonate) bonded to feldspathic porcelain restorations. Search Methods. A search was conducted for articles published between January 1990 and February 2021 in PubMed, MeSH, Scopus, Web of Science, Cochrane, Google Scholar, and reference lists. Eligibility Criteria. English-language articles comparing SBS of feldspathic porcelain’s surface preparation methods for metal/ceramic/polycarbonate orthodontic brackets were included. Articles comparing silanes/bonding agents/primers without assessing roughening techniques were excluded. Data Analysis. Studies were summarized and risk of bias assessed. Each treatment’s SBS was compared with the 6 and 10 MPa recommended thresholds. Studies including comparator (HF hydrofluoric acid + silane + bonding) were candidates for meta-analysis. ARI scores were dichotomized. Fixed- and random-effects models were used and forest plots drawn. Egger regressions and/or funnel plots were used to assess publication biases. Results. Thirty-two studies were included (140 groups of SBS, 82 groups of ARI). Bond strengths of 21 studies were meta-analyzed (64 comparisons in 14 meta-analyses). ARIs of 12 articles were meta-analyzed (28 comparisons in 8 meta-analyses). Certain protocols provided bond strengths poorer than HF + silane + bonding: “abrasion + bonding, diamond bur + bonding, HF + bonding, Nd:YAG laser (1 W) + silane + bonding, CO2 laser (2 W/2 Hz) + silane + bonding, and phosphoric acid + silane + bonding.” Abrasion + HF + silane + bonding might act almost better than HF + silane + bonding. Abrasion + silane + bonding yields controversial results, being slightly (marginally significantly) better than HF + silane + bonding. Some protocols had controversial results with their overall effects being close to HF + silane + bonding: “Cojet + silane + bonding, diamond bur + silane + bonding, Er:YAG laser (1.6 W/20 Hz) + silane + bonding.” Few methods provided bond strengths similar to HF + silane + bonding without much controversy: “Nd:YAG laser (2 W) + silane + bonding” and “phosphoric acid + silane + bonding” (in ceramic brackets). ARIs were either similar to HF + silane + bonding or relatively skewed towards the “no resin on porcelain” end. The risk of bias was rather low. Limitations. All the found studies were in vitro and thus not easily translatable to clinical conditions. Many metasamples were small. Conclusions. The preparation methods HF + silane + bonding, abrasion + HF + silane + bonding, Nd:YAG (2 W) + silane + bonding, and phosphoric acid + silane + bonding (in ceramic brackets) might provide stronger bonds.
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DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
A recently discovered coronavirus, SARS-CoV-2, caused a global respiratory disease pandemic called COVID-19. Many studies have shown the excessive activation of the innate immune response that leads ...to the adverse outcomes of COVID-19, and anti-inflammatory drugs are very useful in the treatment and management of this infection. The activities of Colchicine, one of the anti-inflammatory drugs, target several pathways related to excessive inflammation of COVID-19. This study aimed to evaluate the efficacy of Colchicine in the treatment of COVID-19 using a meta-analysis approach. Scopus, Pubmed, Google scholars, Web of Science, and Science direct were used to search all the randomized controlled trials, case-control, and cross-sectional studies that have evaluated the efficacy of Colchicine as a treatment for COVID-19 (up to 28 May 2021). The overall effect of Colchicine versus the control group was determined using a random-effects model meta-analysis where we compared changes (i.e. mean differences—Colchicine group vs Control group) between the two conditions in test scores indicative of hospitalization time (day) and mortality rate. The results illustrated Colchicine therapy is associated with a decreased mortality rate in COVID-19 patients and associated with a decrease in hospitalization time (day) in COVID-19 patients. Present preliminary data shows that Colchicine has a beneficial effect on coronavirus disease care in 2019. Therefore, Colchicine can be a good suggestion in the management of COVID-19.
Rheumatoid arthritis (RA) is a chronic autoimmune disease caused by established chronic inflammation. Neopterin levels have extensively been considered as a marker of immune activation during ...inflammation. In this study, we performed a systematic evaluation and meta‐analysis to elucidate the overall relationship between neopterin concentration and RA disease activity. Following the Preferred Reporting Items for Systematic Reviews and Meta‐Analysis guidelines, a systematic review was conducted using PubMed, Google Scholar, Web of Science, and Scopus from 2000 to August 2020. The Newcastle–Ottawa scale was used to assess the quality of eligible studies. The effect size (ES) and corresponding 95% confidence intervals (CIs) were calculated to evaluate this association. A total of 15 studies out of 98 met our inclusion criteria. The pooled analysis found that patients with RA had high level of neopterin; however, no statistically significant association was found between neopterin levels with high, intermediate, and low diseases activity score (DAS)‐28 (ES =11.18, 95% CI: 6.02 to 16.34, and I2 = 91.8%; and ES = 8.57, 95% CI: 6.41 to 10.37, and I2 = 99.5%; and ES =12.45, 95% CI: −1.68 to 26.58, and I2 = 99.0%, respectively). Our results indicated that the neopterin concentration does not seem to have any substantial impact on the RA disease activity.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
A rapid outbreak of novel coronavirus, coronavirus disease‐2019 (COVID‐19), has made it a global pandemic. This study focused on the possible association between lymphopenia and computed tomography ...(CT) scan features and COVID‐19 patient mortality. The clinical data of 596 COVID‐19 patients were collected from February 2020 to September 2020. The patients' serological survey and CT scan features were retrospectively explored. The median age of the patients was 56.7 ± 16.4 years old. Lung involvement was more than 50% in 214 COVID‐19 patients (35.9%). The average blood lymphocyte percentage was 20.35 ± 10.16 (normal range, 20%–50%). Although the levels of C‐reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were high in more than 80% of COVID‐19 patients; CRP, ESR, and platelet‐to‐lymphocyte ratio (PLR) may not indicate the in‐hospital mortality of COVID‐19. Patients with severe lung involvement and lymphopenia were found to be significantly associated with increased odds of death (odds ratio, 9.24; 95% confidence interval, 4.32–19.78). These results indicated that lymphopenia < 20% along with pulmonary involvement >50% impose a multiplicative effect on the risk of mortality. The in‐hospital mortality rate of this group was significantly higher than other COVID‐19 hospitalized cases. Furthermore, they meaningfully experienced a prolonged stay in the hospital (p = .00). Lymphocyte count less than 20% and chest CT scan findings with more than 50% involvement might be related to the patient's mortality. These could act as laboratory and clinical indicators of disease severity, mortality, and outcome.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Background
The COVID‐19 outbreak has exerted a great deal of psychological pressure on Iranian health workers and the general population. The aim of this study was to determine the effect of pandemic ...on anxiety and depression in Iranian population.
Methods
An online cross‐sectional study was conducted for the general public and healthcare workers in Iran using a questionnaire comprised of demographic questions and Hospital Anxiety and Depression Scale. Chi‐square test and univariate and multivariate logistic regression models were conducted.
Results
Of the 2045 participants, 1136 (65.6%) were considered to have moderate and severe anxiety symptoms, and 865 (42.3%) had moderate and severe depression symptoms. The prevalence of anxiety was higher in the females than in the males (OR = 1.4, 95% CI: 1.123‐1.643, P = .002); the prevalence of anxiety was significantly higher in those aged 30‐39 years than in other age‐groups (OR = 1.6, 95% CI: 1.123‐2.320, P = .001); furthermore, the prevalence of anxiety and depression was significantly higher in doctors and nurses compared with other occupations ((OR = 1.9, 95% CI: 1.367‐2.491, P < .001) and (OR = 1.5, 95% CI: 1.154‐2.021, P = .003)). In addition, the prevalence of anxiety symptoms in the likely infected COVID‐19 group was higher than in the noninfected COVID‐19 group (OR = 1.35, 95% CI: 1.093‐1.654, P = .005).
Conclusions
Regarding the high prevalence of anxiety and depression symptoms, especially among healthcare workers, appropriate psychological/psychiatric intervention necessitates.
An online cross‐sectional study was conducted for the general public and healthcare workers in Iran using a questionnaire comprised of demographic questions and Hospital Anxiety and Depression Scale. Regarding the high prevalence of anxiety and depression symptoms, especially among healthcare workers, appropriate psychological/psychiatric intervention necessitates.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
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