An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a in severe COVID-19: The COVIFERON II randomized controlled trial.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) has been a serious obstacle in front of public health. Interferon-beta 1a (IFN-ß 1a) has been used to treat patients with COVID-19. We aimed to compare the effectiveness of high-dose IFN-ß 1a compared to low dose IFN-ß 1a in severe COVID-19 cases. METHODS: In this randomized, controlled, and clinical trial, eligible patients with confirmed SARS-CoV-2 infections were randomly assigned to receive one of the two following therapeutic regimens: The intervention group was treated with high-dose IFN-ß 1a (Recigen) (Subcutaneous injections of 88 µg (24 million IU) on days 1, 3, 6) + lopinavir /ritonavir (Kaletra) (400 mg/100 mg twice a day for 10 days, orally) and the control group was treated with low-dose IFN-ß 1a (Recigen) (Subcutaneous injections of 44 µg (12 million IU) on days 1, 3, 6) + lopinavir /ritonavir (Kaletra) (400 mg/100 mg twice a day for 10 days, orally). RESULT: A total of 168 COVID- 19 confirmed patients underwent randomization; 83 were assigned to the intervention group and 85 were assigned to the control group. Median Time To Clinical Improvement (TTIC) for cases treated with low-dose IFN-ß1a was shorter than that for cases treated with high-dose IFN-ß1a (6 vs 10 days; P = 0.018). The mortality rates in intervention and control group were 41% and 36.5%, respectively. CONCLUSION: The use of high-dose IFN-ß 1a did not improve TTCI in hospitalized patients with moderate to severe COVID-19. Also, it did not have any significant effect on mortality reduction compared with treating with low-dose IFN-ß 1a. TRIAL REGISTRATION: This trial has been registered as ClinicalTrials.gov, NCT04521400.

Effects of flaxseed and flaxseed oil supplement on serum levels of inflammatory markers, metabolic parameters and severity of disease in patients with ulcerative colitis.

OBJECTIVE: The present study aimed to evaluate the possible effect of grounded flaxseed and flaxseed oil on serum levels of inflammatory markers, metabolic parameters, and the severity of disease in patients with UC. METHODS: In this open-labeled randomized controlled trial, 90 UC patients were randomly assigned to one of the 3 groups for 12 weeks: grounded flaxseed (GF; 30 g/day), flaxseed oil (FO; 10 g/day) and control group. The weight, waist circumference, systolic and diastolic blood pressure, serum inflammatory markers (interleukin-6 (IL-6), interferon gamma (INF-γ), transforming growth factor beta (TGF-ß), and Erythrocyte Sedimentation Rate (ESR)), and fecal calprotectin were measured at the baseline and end of the study. RESULTS: Totally, 75 patients (43 men and 32 women) with a mean age of 31.54 ±â€¯9.84 years participated in the present study. Comparing the change of the variables indicated a significant decrease in fecal calprotectin (P < 0.001), Mayo score (P < 0.001), ESR (P < 0.001), INF-γ (P < 0.001), IL-6 (P < 0.001), waist circumference (P = 0.02), Diastolic Blood Pressure (DBP) (P < 0.001), and Systolic Blood Pressure (SBP) (P < 0.001) and a significant increase in TGF-ß (P < 0.001) and Inflammatory Bowel Disease Questionnaire-Short form (IBDQ-9) score (P < 0.001) in the GF and FO groups compared to the control. No difference was obvious between the FO and GF groups except for TGF-ß. CONCLUSION: The present study showed that both flaxseed and flaxseed oil, attenuate inflammatory markers, disease severity, blood pressure, and WC. However, the effect of flaxseed on weight and BMI was not evident.

Non-erosive reflux disease compared with erosive esophagitis with regards to acid reflux and symptom patterns.

BACKGROUND/AIMS: Non-erosive reflux disease and erosive esophagitis are the most common phenotypic presentations of gastroesophageal reflux disease. Recent reports suggest that patients with non-erosive reflux disease treated with antireflux medications show lower symptom improvement rates than patients with erosive esophagitis treated with the same medications. The aim was to assess the acid reflux and symptom patterns of patients with non-erosive reflux disease in comparison with those with erosive esophagitis and to identify different non-erosive reflux disease subgroups. MATERIAL AND METHODS: One hundred and twenty consecutive patients (67 male, age: 37.6±12.9 years) seen for classic heartburn symptoms were evaluated for the study. The patients underwent upper endoscopy and 24-hour ambulatory pH monitoring. RESULTS: Erosive esophagitis was identified in 51 patients and nonerosive reflux disease in 69 patients. According to pH metric findings (DeMeester Score >14.72 or Fraction Time >4%), 31.9% of the non-erosive reflux disease group and 47.1% of the erosive gastroesophageal reflux disease group had abnormal acid reflux (p=0.134). Erosive esophagitis patients showed a similar pattern of acid reflux to non-erosive reflux disease patients in the different positions (supine and upright). Non-erosive reflux disease-negative (normal pH test) patients demonstrated a significantly lower degree of esophageal acid exposure when compared with those with erosive esophagitis. About 10.6% of the non-erosive reflux disease-negative patients and 45.5% of the non-erosive reflux disease-positive (abnormal pH test) patients had a positive symptom index (≥50%) during the distal pH metry (p=0.003). CONCLUSIONS: Acid reflux characteristics and symptom patterns suggest that the non-erosive reflux disease group represents a heterogeneous group of patients.