Assessment of the Effect of Sub-Cutaneous Adalimumab on Prognosis of COVID-19 Patients: a Non-Randomized Pilot Clinical Trial Study in Iran.

BACKGROUND: Adalimumab is an anti-inflammatory medicine used to treat a variety of disorders, although its effectiveness in improving the clinical status of COVID-19 patients is debatable. The goal was to evaluate the efficacy of adalimumab as an alternate treatment in COVID-19 patients. METHODS: This non-randomized pilot clinical trial study included 18 patients with severe COVID-19 status hospitalized at the Afzalipour Hospital in Kerman from February 2022 to March 2022. Patients were divided into two groups: nine patients in the control group received dexamethasone, remdesivir, and heparin in addition to supportive therapies. The case group also included nine patients who received adalimumab injection (CinnoRA®, CinnaGen, Iran) in addition to the treatment administered to the control group. RESULTS: Although the effect of adalimumab injection on clinical factors, including mechanical ventilation required, the number of days oxygen needed, the length of stay in the intensive care unit (ICU), and saturation of peripheral oxygen (SpO2) level and respiratory rate (RR), were not significantly different between groups, the intra-group SpO2 level before and after receiving oxygen was significantly different in the case group (p ≤ 0.001 and p = 0.002). In addition, laboratory tests for lactate dehydrogenase (LDH) and C-reactive protein (CRP) revealed no statistically significant differences between the two groups. Nonetheless, a positive intra-group effect of the medication was detected on these two parameters. No short-term side effects of drug injection were observed. CONCLUSIONS: This study demonstrated the efficacy of adalimumab as an alternate medication for improving SpO2, LDH, and CRP levels in COVID-19 patients.

The association of dietary phytochemical index and nonalcoholic fatty liver disease.

Consumption of phytochemical-rich foods relates to the prevention of chronic diseases. In this study we assessed the dietary phytochemical index (PI) in metabolic parameters, liver enzymes, and severity of fibrosis among nonalcoholic fatty liver disease patients. This cross-sectional study was conducted on 210 patients with NAFLD. Fibrosis-4 index (FLB4), nonalcoholic fatty liver disease fibrosis score (NFS), FBS, lipids profile, AST, ALT, ALP, and GGT were measured. PI was calculated through the information obtained from a validated semi-quantitative food frequency. Multiple regression models were used to estimate mean difference changes in the evaluated variables associated with various dietary PI. Participants' mean ± SD of age and BMI were 39.23 ± 10.52 and 24.40 ± 2.64, respectively. We found that DPI is inversely associated with serum TG, TC, and LDL-C and directly associated with serum HDL-C and a higher score in DPI is associated with lower scores in NFS and FIB-4. Multivariate linear regression showed that there is an inverse association between DPI and AST, ALT, ALP, GGT, NFS, and FIB-4. Higher dietary PI could impact on reduction of NAFLD progression and improvement of metabolic parameters.

Clinical evaluation of the effect of Zataria multiflora Boiss and Trachyspermum copticum (L.) on the patients with irritable bowel syndrome.

BACKGROUND AND AIM: Irritable Bowel Syndrome (IBS) is the most common gastrointestinal dysfunction characterized by abdominal pain or discomfort, as well as changes in bowel movements and stool shape. Given the global trend towards the increased use of complementary and alternative medicine (CAM), the high prevalence of IBS, the lack of a standard treatment for all IBS subtypes, and patients' willingness to use CAM treatments, investigations into CAM treatments are needed. Accordingly, the present study aimed to investigate the effect of a mix of two herbal medicines (Zataria-Trachyspermum, ZT) on the clinical symptoms of patients with IBS. EXPERIMENTAL PROCEDURE: The present study was performed on 3 groups including the positive control, experimental, and placebo groups. The sample size was calculated as 150 participants. Fifty patients were assigned to one of three parallel groups (ZT capsule, placebo, and mebeverine capsule) by block randomization. All three groups were treated for 4 weeks. The patients were monitored in the follow-up stage for 2 additional weeks. RESULTS: After the fourth week of intervention, symptoms of pain, bloating, and reflux showed a significant decrease in the ZT group compared to the placebo and mebeverine groups (P <0.05). Moreover, the participants in the ZT group reported a significant decrease in fatigue compared to the other two groups (P <0.05). CONCLUSION: This study confirmed the positive effect of ZT on IBS symptoms, especially pain, bloating, constipation, and bowel movements.

Assessment of the effect of sachet formulation of almond (Amygdalus dulcis L.) on diarrhea prominent irritable bowel syndrome (IBS-D) symptoms: A clinical trial.

OBJECTIVES: Almond has been listed in the low FODMAPs (Fermentable Oligo-, Di-, Mono saccharides And Polyols) and is recommended for infant diarrhea and gastrointestinal problem in Iranian folk medicine. In this work, sachet of almond has been designed, formulated and is studied on the clinical symptoms of diarrhea prominent irritable bowel syndrome (IBS-D). DESIGN: almond was standardized on the basis of total protein and carbohydrate content. A sachet of almond and wheat flour (placebo) was formulated and their physicochemical characteristics were investigated. INTERVENTION: In a double blind randomized trial, fifty IBS-D patients were randomly enrolled into the almond and placebo groups, ranked in respect to the severity of symptoms to mild-moderate and severe disease. The patients received almond or placebo sachet (40 g/day,20 days) respectively. MAIN OUTCOME MEASURE: Patients were assessed for bowel habit, pain severity and frequency and bloating and data was recorded in a data collecting form. RESULTS: The results showed that none of the primary outcomes of the disease is improved in the patients treated with almond. The bowel movement and severity of the pain was significantly increased in the almond treated patients compared to the placebo and baseline (p < 0.05). CONCLUSION: Almond contains high content of oligo-fructan which in high intake might result in a large amount of fermentable carbohydrates that can exacerbate the symptoms of the disease. So, despite the almond inclusion in the low-FODMAPs, the amount of almond intake is a determining factor and here we have controversial results for almond intake in patients with IBS. Mental health and physical activity of patients are also involved in the disease.

Effect of Apium graveolens and Trachyspermum copticom on clinical symptoms of patients with functional dyspepsia.

OBJECTIVES: This study aimed at investigating the effect of Iranian traditional remedy prepared from Apium graveolens and Trachyspermum copticom (AT) on the severity and frequency of symptoms in patients with functional dyspepsia (FD). MATERIAL AND METHODS: In total, 150 FD patients were included in this randomized double-blind trial, based on the ROME III diagnostic criteria, and they were divided into three intervention groups namely, AT, Placebo and omeprazole. Then, severity and frequency of symptoms during this eight-week trial were measured. Obtained information was analyzed using Chi-square test and repeated measures test. RESULT: In general, the severity and frequency of symptoms after the 4th week significantly decreased in the AT group as compared to the omeprazole and placebo groups, and continued to reduce by the end of the eighth week. General reduction of symptom severity and frequency in the omeprazole group was significantly different from the placebo group by the end of the 4th and 8th weeks. With respect to each individual symptom, AT markedly improved symptoms, such as burning, pain, early satiation, fullness, bloating, belching and nausea, as compared to placebo-treated group. Moreover, AT significantly improved symptoms, like vomiting, and nausea, except for pain, as compared to omeprazole-treated subjects. CONCLUSION: According to the results, AT, as Iranian traditional remedy, was more effective than omeprazole and placebo in reducing the symptoms in FD patients.

Evaluating the safety, efficacy and complications of electrotherapy and its comparison with conventional method of hemorrhoidectomy.

AIM: This study was performed to evaluate the efficacy, safety and complications of electrotherapy compared with conventional hemorrhoidectomy (Ferguson technique). BACKGROUND: Ferguson hemorrhoidectomy is always associated with considerable pain and postoperative complications. Still, the electrotherapy method in which the hemorrhoidal tissue is not removed may not improve critical complications. PATIENTS AND METHODS: This randomized clinical trial was performed on patients with hemorrhoids referring to hospitals affiliated to the Kerman University of Medical Sciences during 2014-2015. One hundred and twenty patients presented with symptomatic hemorrhoids grade I, II, III, and IV were randomized into two groups. Group 1 (60 patients) underwent electrotherapy using 30 mA direct current and group 2 (60 patients) were submitted to Ferguson hemorrhoidectomy. The groups were compared regarding postoperative pain severity and complications, including recurrent symptoms, infection and recovery time to return to normal activities. The p≤ 0.05 was considered statistically significant. RESULTS: More than 70% of patients in group 2 complained of severe pain, but in group 1, no more than 30% of patients experienced severe pain up to 6 hours post-surgery and 70% complained of mild pain 2-3 days post-surgery. Twenty four-hour hospitalization in group 2 and group 1 were 97% and 78%, respectively, whilst patients in electrotherapy group could be treated as outpatients. The mean return time to usual activities was 15 and 1.5 days for group 2 and 1, respectively. CONCLUSION: Electrotherapy with a direct current of 30 mA significantly reduce postoperative pain and the recovery period. This method showed a good success rate and less complication than the Ferguson method. As a result, because of more effectiveness, less pain, as well as shorter recovery time and getting back to normal activities, we recommend this procedure for the treatment of symptomatic hemorrhoids grade I, II, and III.

Determination of cytomegalovirus prevalence and glycoprotein B genotypes among ulcerative colitis patients in ahvaz, iran.

BACKGROUND: The human cytomegalovirus (HCMV) is a common pathogen which usually remains asymptomatic in the healthy adults; however, it can cause a symptomatic disease in the immunocompromised patients. The risk of infection with HCMV increases in ulcerative colitis (UC) patients as a result of receiving immunosuppressive agents. OBJECTIVES: This study aimed to determine the prevalence and the glycoprotein B genotypes of HCMV among the patients with HCMV disease superimposed on an UC flare that required hospitalization in Imam Khomeini Hospital in Ahvaz, Iran, during 2010- 2012. PATIENTS AND METHODS: In this case-control study, formalin-fixed paraffin-embedded intestinal tissue samples were taken from 98 patients with UC disease including 53 males and 45 females (mean age ± standard deviation, 38.95 ± 17.93) and 67 control patients with noninflammatory disease who were referred to Imam Khomeini Hospital during 2010-2012. Detection of HCMV genome in intestinal samples was carried out by seminested polymerase chain reaction. Glycoprotein B genotypes were determined by sequencing. RESULTS: Among 98 patients with UC, only 12 (12.2%) patients were positive for HCMV genome, while the HCMV genome was not detected in any of the controls. (P = 0.002). The distribution of HCMV gB genotypes in 12 CMV-positive UC patients was as follow: gB1, 11 (91.7%) and gB3, 1 (8.3%). The most prevalent genotype in CMV-positive UC patients was gB1. CONCLUSIONS: In this study, high prevalence of 91.7% HCMV gB1 genotype was predominant among HCMV-positive UC patients, which suggests that there might be an association between HCMV gB genotype 1 and UC disease.

Dietary Factors in Relation to Helicobacter pylori Infection.

Background and Aim. Helicobacter pylori (HP) and diet are both risk factors for gastric cancer. The aim of this study was to evaluate the Helicobacter pylori infection and dietary habits common in Khuzestan province. Methods. This cross-sectional study was conducted in 2011-2013 on 374 patients. Participants were interviewed using a food frequency questionnaire and tissue sample of the antrum was sent for pathology lab. The histopathological major variables were graded on a scale of 3 (mild, moderate, and severe) and data analyzed using nonparametric tests. Results. In this study, of 160 patients (43%) that were determined, 8.1 percent had severe contamination. Among dietary patterns, relationship between energy intake and carbohydrate with H. pylori was significant. A direct association was found between mean daily intakes of sausage (P = 0.001) and burgers (P < 0.05) with HP infection. Low intake of fresh vegetables and fruits was the most significant risk factors (P < 0.05). Conclusion. There is a possibility that some dietary factors such as consumption of fast foods and low intake of fresh vegetables may increase the chance of HP and severity of this infection.

Endothelial dysfunction in Iranian lupus patients.

Atherosclerosis has a high prevalence in systemic lupus erythematosus (SLE) patients and vascular endothelial dysfunction is the earliest stage of atherosclerosis. The aim of this study was to evaluate the prevalence of vascular endothelial dysfunction and its risk factors in SLE patients and to identify its correlation with disease activity, duration and concomitant conditions in these patients. A total of 84 female SLE patients and 18 healthy young women were included. The vascular endothelial function was evaluated via ultrasonographic assessment of the brachial artery diameter to determine flow-mediated dilation (FMD) and post-TNG dilation-FMD gap (PFG) indexes. FMD indexes of one standard deviation lower than mean FMD of the control group were considered as impaired, and PFG indexes of one standard deviation more than mean PFG of the control group were defined as impaired. SLE patients had a higher prevalence of impaired FMD than healthy subjects (48.8 vs. 5.5%). The prevalence of impaired PFG in SLE cases and healthy subjects was 25 and 5.5%, respectively. FMD and PFG impairment did not have any significant correlation with disease activity, duration, presence of anti-dsDNA, anticardiolipin antibodies, antiphospholipid syndrome and history of receiving cyclophosphamide pulses. Vascular endothelial dysfunction is very common in SLE patients and no single specific factor can explain this finding. We recommend the application of brachial artery Doppler ultrasound as a screening test for detection of early stages of atherosclerosis in SLE patients.