A Pilot Study of the Effectiveness of a Short Course of Rifaximin 2200 mg/day on Abdominal Symptoms and its Effects on Quality of Life in Patients with Moderate to Severe Diarrhea-Predominant Irritable Bowel Syndrome.

BACKGROUND AND OBJECTIVE: Rifaximin is used to treat diarrhea-predominant irritable bowel syndrome (IBS-D). However, determining the most effective regimen remains a challenge. This study aimed to evaluate the effectiveness and safety of a 10-day high-dose course of rifaximin (2200 mg/day) and its effects on both abdominal symptoms and quality of life (QOL) in patients with IBS-D. METHOD: Adult patients with moderate to severe IBS-D (Rome IV) and fecal urgency and bloating were prescribed rifaximin 1100 mg twice daily for 10 days. Demographic information, the IBS Symptom Severity Index (IBS-SSI) score (using a 7-point Likert scale), and Bristol Stool Scale (BSS) score were recorded at baseline, day 10, and 4 weeks after treatment cessation. IBS Symptom Severity Score (IBS-SSS) and IBS-QOL scores were recorded at baseline and day 10. Any drug adverse effects were recorded. RESULTS: In total, 39 patients completed the study. Average scores for all abdominal symptoms and BSS showed significant improvement at day 10 and 4 weeks after treatment cessation (all p < 0.001). A significant improvement was seen in IBS-SSS and overall IBS-QOL score at day 10 (p < 0.001), with the highest improvement (31%) in interference with activity. Moreover, composite improvement rates were 38.64% for all abdominal symptoms, together with BSS < 5, bi-composite (66.67% for abdominal pain + bloating; 61.54% for abdominal pain + urgency), and 56.41% for tri-composite (abdominal pain + bloating + urgency) symptoms. Notably, no serious adverse effects were reported, and the adherence rate was 94.9%. CONCLUSIONS: Abdominal symptoms and overall QOL, especially in social and work dimensions, significantly improved in patients with moderate to severe IBS-D following a regimen of rifaximin 2200 mg/day, which was well tolerated.

The role of cognitive emotion regulation strategies in predicting the resilience, symptom severity, and quality of life of patients with irritable bowel syndrome.

BACKGROUND: Psychosocial stressors contribute to the development of irritable bowel syndrome (IBS) and exacerbate the symptoms. The capability to cope with stress is an essential element in the management of IBS. This study assessed nine cognitive emotion regulation strategies (CERS) and their role in predicting symptom severity, quality of life (QOL), and resilience in IBS subjects. METHODS: The scores regarding nine subscales of CERS were obtained by cognitive emotion regulation questionnaire (CERQ) and compared between study patients based on the severity and subtypes of IBS using one-way ANOVA. To evaluate the predictive role of CERS, logistic regression was performed. The correlation between CERS and the QOL was assessed by Pearson correlation analysis. The score of resilience was measured by Connor-Davidson Resilience Scale (CD-RISC). RESULTS: We recruited 100 patients diagnosed with IBS based on ROME IV criteria. Among nine subscales of CERS, patients with more severe symptoms scored higher in catastrophizing (p < 0.001) and blaming others (p = 0.015) while lower in positive reappraisal (p = 0.028). Blaming others was the only predictor of resilience and severity of IBS in our patients (odds ratio (OR): -2.103, p=0.028, and OR:1.715, p = 0.049, respectively). We observed significant negative correlations between the quality of life and rumination (r= -0.202, p=0.044), self-blame (r= -0.241, p=0.016), catastrophizing (r= -0.342, p<0.001), and blaming others (r= -0.219, p=0.028). CONCLUSION: Maladaptive strategies are more common in IBS patients with more severe symptoms and have negative correlations with the QOL. Blaming others has the potential to predict the resilience and severity of symptoms in IBS patients.

Intensive short-term dynamic psychotherapy for irritable bowel syndrome: a randomized controlled trial examining improvements in emotion regulation, defense mechanisms, quality of life, and IBS symptoms.

Studies have provided evidence for the effectiveness of intensive short-term dynamic psychotherapy (ISTDP) in treating medically unexplained symptoms (MUS). This study aimed to examine the effectiveness of ISTDP on individuals living with irritable bowel syndrome (IBS) in terms of, emotion regulation (ER) abilities, defense mechanisms, quality of life (QOL), and IBS symptoms. A total of 30 patients diagnosed with IBS were recruited and randomly assigned to either the intervention (n = 15) or control (n = 15) group. Pre- and post-treatment assessments were conducted, along with a follow-up assessment after ten weeks. Repeated measures analyses of variance were employed to analyze the data. The findings revealed that ISTDP led to significant improvements in ER, defense mechanisms, and QOL, as well as a reduction in the severity and frequency of IBS symptoms. These results provide further support for the efficacy of ISTDP as a treatment modality for individuals with IBS.

Investigation about the correlation between the severity of metabolic-associated fatty liver disease and adherence to the Mediterranean diet.

BACKGROUND: Metabolic-associated fatty liver disease (MAFLD) is defined by fatty liver combined with a disturbed metabolic state. Mediterranean diet (MedDiet) contains anti-inflammatory, anti-oxidative, and anti-fibrotic components and is seemingly beneficial in the management of MAFLD. We aimed to evaluate the correlation between adherence to MedDiet and the severity of MAFLD. MATERIALS AND METHODS: Totally 101 adult patients diagnosed with MAFLD were enrolled in this cross-sectional study. Persian version of Mediterranean Diet Adherence Screener (MEDAS), demographics, clinical, laboratory, and FibroScan findings were collected. Correlation and regression analyses were performed. RESULTS: The mean of participants' age was 49.37 ± 12.14 (51.48 % male subjects). Six patients (5 diabetic and 1 pre-diabetic) had advanced fibrosis. Overall, 48.5 % had good adherence to MedDiet [the least MEDAS-1 (15.8 %) and the highest MEDAS-13 (99 %)]. The adherence score was significantly higher in married, female, non-smoker, and diabetic subjects, and patients with hypertension. Adherence to MedDiet had insignificant correlations with hepatic fibrosis (P = 0.888), steatosis (P = 0.208), waist-to-height ratio (P = 0.853), and FIB-4 score (P = 0.919). Vitamin D level had just significant inverse associations with steatosis score (r = -0.21, P = 0.037) and no significant association was found with fibrosis score (r = -0.036, P = 0.717) and MedDiet adherence (r = 0.055, P = 0.581). According to the multiple regression analyses, less fruit intake, lower platelet count and DM had significant positive correlations with MAFLD severity (P < 0.001). CONCLUSION: Adherence to Mediterranean diet, particularly a higher fruit intake, is associated with a lower severity of MAFLD. Dietary modification based on taste, economic state, and culture should be deliberated in different geographic areas along with nutritional education.

The effect of Trolox on the rabbit anal sphincterotomy repair.

INTRODUCTION: Fecal incontinence (FI) is caused by external anal sphincter injury. Vitamin E is a potential strategy for anal sphincter muscle repair via its antioxidant, anti-inflammatory, anti-fibrotic, and protective properties against myocyte loss. Thus, we aimed to evaluate the water-soluble form of vitamin E efficacy in repairing anal sphincter muscle defects in rabbits. METHODS: Twenty-one male rabbits were equally assigned to the intact (without any intervention), control (sphincterotomy), and Trolox (sphincterotomy + Trolox administration) groups. Ninety days after sphincterotomy, the resting and squeeze pressures were evaluated by manometry, and the number of motor units in the sphincterotomy site was calculated by electromyography. Also, the amount of muscle and collagen in the injury site was investigated by Mallory's trichrome staining. RESULTS: Ninety days after the intervention, the resting and squeeze pressures in the intact and Trolox groups were significantly higher than in the control group (P = 0.001). Moreover, the total collagen percentage of the sphincterotomy site was significantly lower in the Trolox group than in the control group (P = 0.002), and the total muscle percentage was significantly higher in the Trolox group compared to the control group (P = 0.001). Also, the motor unit number was higher in the Trolox group than in the control group (P = 0.001). CONCLUSION: Trolox administration in the rabbit sphincterotomy model can decrease the amount of collagen and increase muscle, leading to improved anal sphincter electromyography and manometry results. Therefore, Trolox is a potential treatment strategy for FI.

Evaluating macro- and micronutrients and food groups intake with the risk of developing inflammatory bowel disease: Is there any association?

Growing clinical evidence represented that certain dietary components are involved in inflammatory bowel disease (IBD) development and progression. This research, therefore, aimed to evaluate whether there exists any relationship between nutrients and IBD. This case-control study from 2017 to 2019 was performed on 145 newly diagnosed IBD patients and 145 BMI-, sex-, and age-matched healthy controls who were recruited from a hospital clinic. A validated 168-item food frequency questionnaire was completed by each participant. Anthropometric measurements and physical activity levels were measured for all participants. Stata software was used to analyze all data. Of the 234 study individuals who participated, 112 were IBD patients and 122 were healthy people. The higher amount of seafood and cholesterol was related to an increased risk of IBD and ulcerative colitis development; however, individuals who had a higher intake of calcium were less likely to have Crohn's compared to the healthy group. There was a positive relation between honey and jam, seafood, organ meats, salt, fruits on trees, fruit juice, olives, and nuts and the probability of IBD, but there was a negative association between refined grains, potatoes, salty snacks, legumes, dairy, and cruciferous and the probability of IBD. Higher consumption of seafood and cholesterol was positively connected with a higher risk of IBD development in the current case-control study. A substantial association was seen between honey and jam, seafood, organmeats, salt, fruit on trees, fruit juice, olives, and nut consumption and IBD developement.

Insulin-like growth factor 1 serum levels in different stages of gastric cancer and their association with Helicobacter pylori status.

High serum insulin-like growth factor 1 (IGF-1) and positive Helicobacter pylori (H. pylori) may increase the risk of gastric cancer (GC). We aimed to investigate IGF-1 serum levels in different stages of GC patients and their association with H. pylori status. A total of 90 participants, including 60 GC patients and 30 noncancerous (NC) individuals, were included in the present study. IGF-1 serum levels and candidate proteins were assessed using enzyme-linked immunosorbent and immunohistochemistry techniques. Likewise, Giemsa staining was applied to detect H. pylori infection. The candidate genes' expression, including IGF-1R, PI3KCA, AKT1, mTOR1, KRAS, BRAF, and ERK1, was also evaluated by a real-time PCR assay. The results of advanced GC stages indicated a significantly high IHC score for IGF-1R and phosphorylated AKT, mTOR, and ERK proteins compared to the early stages. Moreover, IGF-1 serum levels and the expression of candidate genes were considerably increased in the advanced GC patients compared to the early stages and the positive H. pylori status compared to the negative H. pylori status (P < 0.05). As a result, high IGF-1 serum levels and positive H. pylori status may be correlated with gastric tumor progression, and the inhibition of IGF-1 and the eradication of H. pylori infection might be new therapeutic targets in GC patients.

The Incidence of Post-infectious Irritable Bowel Syndrome, Anxiety, and Depression in Iranian Patients with Coronavirus Disease 2019 Pandemic: A Cross-Sectional Study.

BACKGROUND: Irritable bowel syndrome refers to a subgroup of disorders of gut-brain interaction associated with stress-related symptoms, but gastrointestinal infection can also be considered the leading risk factor. It is well reported that coronavirus disease 2019 can also result in gastroenteritis. Therefore, this study aimed to evaluate the incidence of post-infectious irritable bowel syndrome and stressful status among coronavirus disease 2019 patients. METHODS: This cross-sectional study was conducted on adults with coronavirus disease 2019 referred to the Infectious Disease Clinic in Iran from November 2020 to February 2021. Patients who met all eligibility criteria were included in the study. The data were collected using a demographic questionnaire, Rome IV criteria questionnaire, and Hospital Anxiety and Depression Scale. RESULTS: Totally, the data obtained from 233 eligible patients (136 women, 97 men; mean age 38.41) 11.52 (years) were collected and analyzed, and 53.2% of the cases had a moderate coronavirus disease 2019. The analysis showed that 27 (11.6%) patients suffered from irritable bowel syndrome symptoms based on Rome IV criteria after the recovery from the infection. Also, Hospital Anxiety and Depression Scale-based symptoms of depression and anxiety that occurred with coronavirus disease 2019 were reported in 27.4% and 36.9%, respectively. CONCLUSION: Our finding illustrated that irritable bowel syndrome symptoms based on Rome IV could occur in post-infected coronavirus disease 2019 patients. Also, Hospital Anxiety and Depression Scale-based symptoms of depression and anxiety were more common in females and coronavirus disease 2019 infected patients with clinical symptoms including cough, shortness of breath, and sore throat.

Alteration of miR-21, miR-433 and miR-590 tissue expression related to the TGF-ß signaling pathway in ulcerative colitis patients.

Ulcerative colitis (UC) is an inflammatory disease, and studies have suggested a role for TGF-ß signalling pathway in the pathogenesis of UC. In the present study, we evaluated expression of TGF-ß signalling genes and their regulatory microRNAs in patients with UC and control subjects. The expression of TGF-ß1, SMAD2, SMAD3, miR-21, miR-101, miR-433, and miR-590 were evaluated using real-time PCR in biopsy samples of the patients and controls. Results showed increased expression of TGF-ß1 and SMAD3 in the patients compared to controls. In addition, miR-21 and miR-433 were found to be higher in the patients compared to controls; however, miR-590 was found to be lower. Moreover, miR-433 was demonstrated to have positive correlation with SMAD3 and TGF-ß while miR-21 was positively correlated with TGF-ß1. MiR-590 was negatively correlated with SMAD2 and SMAD3. Results of the present study suggested a role for TGF-ß signalling pathway related microRNAs in pathogenesis of UC.

Combined application of chondroitinase ABC and photobiomodulation with low-intensity laser on the anal sphincter repair in rabbit.

BACKGROUND: Photobiomodulation with low-intensity laser (LIL) and chondroitinase ABC (ChABC) can repair damaged muscle tissue, so the aim of this study was to investigate the effect of co-administration of these two factors on anal sphincter repair in rabbits. METHODS: Male rabbits were studied in 5 groups (n = 7): Control (intact), sphincterotomy, laser, ChABC and laser + ChABC. 90 days after intervention were evaluated resting and maximum squeeze pressures, number of motor units, collagen amount, markers of muscle regeneration and angiogenesis. RESULTS: Resting pressure in the Laser + ChABC group was higher than the sphincterotomy, laser and ChABC groups (p < 0.0001). Maximum squeeze pressure in the all study groups was higher than sphincterotomy group (p < 0.0001). In the laser + ChABC and ChABC groups, motor unit numbers were more than the sphincterotomy group (p < 0.0001). Collagen content was significantly decreased in the laser (p < 0.0001) and laser + ChABC groups. ACTA1 (p = 0.001) and MHC (p < 0.0001) gene expression in the Laser + ChABC group were more than the laser or ChABC alone. VEGFA (p = 0.009) and Ki67 mRNA expression (p = 0.01) in the Laser + ChABC group were more than the laser group, But vimentin mRNA expression (p < 0.0001) was less than the laser group. CONCLUSION: Co-administration of ChABCs and photobiomodulation with LIL appears to improve the tissue structure and function of the anal sphincter in rabbits more than when used alone.

Investigation the Effectiveness of Duloxetine in Quality of Life and Symptoms of Patients with Irritable Bowel Syndrome.

BACKGROUND: Selective norepinephrine-serotonin receptor inhibitors (SNRIs) such as duloxetine have already shown beneficial effects on symptoms in irritable bowel syndrome (IBS) patients. The purpose of the present investigation was to assess the efficacy of duloxetine in the symptom and quality of life improvement in diarrhea predominant-IBS (IBS-D) patients. MATERIALS AND METHODS: IN a randomized, double-blind and placebo-controlled study, sixty patients diagnosed with IBS-D (ROM-IV criteria), referred to the gastrointestinal clinic of Rasoul-e-Akram Hospital of Iran university of medical sciences, randomly assigned in the treatment groups, group A: patients who received 135 mg mebeverine tablet twice a day combined with 30 mg duloxetine capsule per day and group B, who received the same regimen, except for placebo capsule once per day instead of duloxetine for twelve weeks. The assessment was performed using the IBS severity index, and IBS quality of life questionnaire (IBS-QOF) at baseline, and weeks 4, 8, and 12 after beginning the treatment. Drug adverse effects and compliance to treatment were evaluated every 2 weeks after starting the treatment. RESULTS: Sixty patients completed the trial. The duloxetine group showed significantly greater improvement on the IBS symptoms (P < 0.001), and the IBS-QOF (P < 0.001) in comparison to the placebo group at the endpoint. CONCLUSIONS: This study showed that adding duloxetine to mebeverine is safe with good efficacy on symptoms and QOL improvement in IBS-D patients. Besides, this study showed that 12 weeks' treatment duration is significantly more effective than 4 weeks' treatment, and drug adverse effects are more prominently seen in the first 2 weeks of treatment.

The effect of adding duloxetine to lansoprazole on symptom and quality of life improvement in patients with gastroesophageal reflux diseases: A randomized double-blind clinical trial.

BACKGROUND: Gastroesophageal reflux disease (GERD) is a common upper gastrointestinal disorder with a negative impact on the quality of life. This study was aimed to assess the effect of adding duloxetine to lansoprazole on the symptom and quality of life improvement in GERD patients. MATERIALS AND METHODS: Seventy adult patients with a complaint of heartburn and regurgitation were enrolled in this randomized trial. Patients with a history of atypical symptoms, advanced systemic disease, medication-induced symptom, structural lesion in endoscopy, allergy to the medication, and unco-operative were excluded. The patients randomly (computer generated table) assigned in Groups A who received lansoprazole 30 mg plus placebo daily and Group B, in which duloxetine 30 mg daily replaced by placebo during 4 weeks. All of participants, care-givers, and outcomes assessors were blinded. Basic demographic data, symptom severity score, depression and anxiety Beck score, and quality of life questionnaire were recorded at the starting and ending of treatment. RESULTS: Fifty-four patients have completed the study. The mean difference of Anxiety Beck score (13, 95% confidence interval [CI] [10-16], P = 0.001) and total raw score of quality of life (7, 95% CI [3.89-10.11], P = 0.043) were significantly improved in Group B. Complete and overall heartburn improvement rates were significantly better in Group B (odds ratio [OR] Adj: 2.01, 95% CI [1.06-2.97] and OR Adj: 1.31, 95% CI [1.05-1.57], respectively). CONCLUSION: We found that the combination of duloxetine and lansoprazole is a safe and tolerable regimen, and it can significantly improve anxiety, heartburn, coffee consumption, the quality of sleep, and life in patients who suffer from the symptoms of GERD.

Effects of vitamin D3 supplementation on clinical symptoms, quality of life, serum serotonin (5-hydroxytryptamine), 5-hydroxy-indole acetic acid, and ratio of 5-HIAA/5-HT in patients with diarrhea-predominant irritable bowel syndrome: A randomized clinical trial.

Vitamin D deficiency, common in the population with irritable bowel syndrome (IBS), can induce the main factors that lead to IBS clinical symptoms, such as depression, anxiety, and inflammation. Serotonin (5-HT) plays an important role in the pathophysiology of IBS, and its production and secretion are increased from the lumen due to stress and inflammation. The aim of this study was to evaluate the effect of vitamin D3 supplementation on the pathogenesis of diarrhea-predominant IBS (IBS-D). Seventy-four IBS-D patients (age: 18-65 y) participated in a randomized, double-blind, placebo-controlled trial study from February 2017 to May 2018, at Rasoul-e-Akram Hospital, Tehran, Iran. Subjects were allocated into two groups receiving 50,000 IU/week of vitamin D3 or placebo for 9 weeks. IBS severity score system (IBS-SSS), IBS-quality of life questionnaire (QoL), hospital anxiety and depression Scale (HADs), visceral sensitivity index (VSI) and serum 25(OH) vitamin D3, serotonin, 5-hydroxy-indole acetic acid and ratio of 5-HIAA/5-HT were evaluated before and after the interventions. Symptoms severity, QoL, HADs-depression, and VSI score improved significantly in the vitamin D group as compared to the placebo group (P-values: <0.001, 0.049, 0.023, and 0.008; respectively). There were no significant differences in abdominal bloating, HADs-anxiety, serum 5-HT, 5-HIAA, and 5-HIAA/5-HT between the two groups at the end of the study. Based on our results, we recommend serum vitamin D be evaluated in the process of treatment of these patients to ameliorate symptoms and quality life of IBS-D patients with vitamin D deficiency and/or insufficiency.

A comparative study of the effect of 10-day esomeprazole containing levofloxacin versus clarithromycin sequential regimens on the treatment of Iranian patients with Helicobacter pylori infection.

OBJECTIVE: Helicobacter Pylori (H. pylori) treatment may be different depending on the host and microbial factors in each region. The study was planned to estimate the effect of two 10-day esomeprazole containing clarithromycin and levofloxacin sequential therapies on H. pylori treatment. MATERIALS AND METHODS: Totally, 186 H. pylori-infected patients with gastro-duodenal ulcer who had not yet received treatment for infection, were enrolled. We randomly designated patients to group A (N = 94) who treated with esomeprazole 40 mg and amoxicillin 1 g bid during the early half of treatment, and continued the same dose of esomeprazole with levofloxacin 500 mg and tinidazole 500 mg bid during the second half of treatment and Group B (N = 92) who treated with the identical treatment excepting clarithromycin 500 mg bid as a substitute of levofloxacin. To assess eradication, C14-urea breath test was implemented 8 weeks afterward treatment. RESULTS: Finally, 172 patients completed the trial. We calculated 85.1% (95% confidence interval [CI] = 77.9-92.3) and 83.7% (95% CI = 76.2-91.2) eradication intention-to-treat analysis (P = 0.302) and so, 93.0% (95% CI = 87.6-98.4) and 90.0% (95% CI = 83.6-96.3) eradication by per-protocol analysis (P = 0.420) for Group A and B, respectively. No significant difference was seen among regimens. Drug adverse reactions were not significantly different between regimens. Group A had a 97.8% adherence rate to treatment and Group B had 98.9%. CONCLUSIONS: Both esomeprazole containing sequential regimens including levofloxacin and clarithromycin showed good eradication rates in spite of significant differences in antimicrobial resistance patterns in vitro. The efficacy of esomeprazole in lowering gastric acidity beside its antimicrobial effect should be considered in H. pylori regimens.

How adding the abdominal massage to polyethylene glycol can improve symptom and quality of life in patients with functional constipation in comparison with each one of the treatment modalities alone: A randomized clinical trial.

BACKGROUND: A variety of medical and non-medical treatments have been introduced for functional constipation relief. Here, we aimed to compare the efficacy of a combination of polyethylene glycol (PEG) and abdominal massage with each one of the treatments alone. MATERIALS AND METHODS: Patients with functional constipation based on Rome IV criteria were randomly assigned into the three treatment groups: group A (abdominal massage for 15 min daily), group B (PEG 20 g daily), and group C (PEG 20 g plus abdominal massage for 15 min daily) for 14 days. PAC-QOL questionnaire, Bristol stool scale were evaluated at baseline and two weeks after treatment. Constipation-associated symptom scores were recorded at baseline, two weeks and four weeks after treatment beginning. Descriptive statistics were provided as the mean ±â€¯standard deviation or number and percentage. P-value<0.05 was considered statistically significant. RESULTS: Forty eight, 47 and 48 patients in group A, B, and C completed the study, respectively. PAC-QOL, Bristol and Constipation-associated symptom scores showed a significant improvement in all study groups two weeks after the treatment compared to the baseline. At the end of treatment, the rate of straining, incomplete evacuation sensation, finger evacuation and the number of defecation was significantly lower in the group C (P < 0.04). Bristol score were significantly improved in group B (P = 0.029) in compare to other groups. The total quality of life score was also significantly improved in the group C (P = 0.028). CONCLUSION: A combination of abdominal massage and PEG is safe, tolerable and more effective than each one of the treatments alone.

A randomized controlled trial of pegylated interferon-alpha with tenofovir disoproxil fumarate for hepatitis B e antigen-negative chronic hepatitis B: A 48-week follow-up study.

BACKGROUND: Recent studies report incongruent finds regarding the addition of pegylated interferon -alpha (Peg- IFNα) to nucleos(t)ide analogues. This study was designed to compare the efficacy of Peg- IFNα and tenofovir disoproxil fumarate (TDF) combination therapy with each of the treatments separately. METHODS: In this open-label, randomized clinical trial, treatment-naive hepatitis B e antigen (HBeAg)-negative patients were randomly assigned to three treatment groups: Group A: Peg- IFNα (180 mcg/week) with TDF (300 mg/day); Group B: TDF (300 mg/day); and Group C: Peg- IFNα (180 mcg/week). The intervention spanned 48 weeks and patients were followed up every 12 weeks. The primary end-point was HBV DNA load <20 IU/mL. RESULTS: Groups A, B and C each comprised of 22, 23 and 22 patients, respectively. The number of patients with HBV DNA suppression in group A was significantly higher compared to groups B and C (P = 0.034). No significant difference was observed in the normalization trends of serum ALT levels between the three groups (P = 0.082). At week 48, combination therapy was significantly more effective in suppressing HBV DNA concentration to below the level of detection than TDF monotherapy (OR = 2.1, 95%CI: 1.18-4.15; P = 0.034). Furthermore, a comparison between monotherapy arms revealed that both interventions had similar effects on the overall outcome (OR = 1.24, 95%CI: 1.02-5.8; P = 0.062). CONCLUSION: A Peg- IFNα and TDF combination therapy resulted in improved virologic response and was safe in HBeAg negative patients. Monotherapy with Peg-IFNα or TDF procured limited benefits in comparison. TRIAL REGISTRATION: This study was registered in the Iranian Registry of Clinical Trials (IRCT20181113041635N1).

The effect of saffron supplementation on some inflammatory and oxidative markers, leptin, adiponectin, and body composition in patients with nonalcoholic fatty liver disease: A double-blind randomized clinical trial.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is characterized by oxidative stress and inflammation in the hepatocytes. Saffron and its constituents are reported to have several properties such as anti-inflammatory and anti-diabetic effects. MATERIALS AND METHODS: In a randomized double-blind placebo-controlled trial with two parallel groups including 76 eligible men and female patients with NAFLD aged 18-65, recruited from Hazrat Rasul Akram Hospital in Tehran, Iran. NAFLD was defined by a Gastroenterologist based on the American Gastrointestinal and Liver Association standards. Participants were randomly assigned to two groups receiving daily supplementation of either one tablet of 100 mg saffron (n = 38) or one placebo (n = 38) for 12 weeks. The primary outcome was high sensitive C-reactive protein (hs-CRP) and secondary outcomes were alanine aminotransferase (ALT), aspartate aminotransferase (AST), tumor necrosis factor alpha (TNF-α), malondialdehyde (MDA), total anti-oxidant capacity (TAC), leptin, adiponectin, anthropometric, and body composition Both groups were assigned similar diet and physical activity. RESULTS: In the treatment group, significant decreases in hs-CRP (-1.80 ng/ml, 95% CI = -2.97, -0.63, p = .032), leptin (-0.27 ng/ml, 95% CI = -0.65, -0.10, p = .040), MDA (-1.01 ng/ml, 95% CI = -1.89, -0.14, p = .023) and significant increase in TAC (0.34 µmol/L, 95% CI = 0.08, 0.61, p = .011) were observed compared to the placebo group. However, there were no significant changes in serum alanine aminotransferase, AST, TNF-α, body composition, and anthropometric indexes (p > .05). CONCLUSION: In the present study, 12 weeks of 100 mg of saffron supplementation indicated beneficial effects on serum levels of some inflammatory, oxidative stress, and adipokines biomarkers but it had no significant effect on serum concentrations of liver enzymes, anthropometric, and body composition measurements.

Vitamin D3 Supplementation in Diarrhea-Predominant Irritable Bowel Syndrome Patients: The Effects on Symptoms Improvement, Serum Corticotropin-Releasing Hormone, and Interleukin-6 - A Randomized Clinical Trial.

OBJECTIVES: This study aimed to evaluate whether vitamin D deficiency is associated with the severity of symptoms of irritable bowel syndrome (IBS) patients. Stress and gut inflammation can increase the serum level of corticotropin-releasing hormone (CRH) and interleukin-6 (IL-6), leading to a change in bowel movements. The aim of this study was to evaluate the anti-inflammatory and psychological effects of vitamin D3 supplementation on the symptom improvement of patients with a diarrhea-predominant form of IBS (IBS-D). METHODS: Eighty-eight IBS-D patients (age: 18-65 years) based on Rome IV criteria who suffered from vitamin D deficiency and/or insufficiency were enrolled in this randomized, placebo-controlled trial from February 2017 to May 2018 at Rasoul-e-Akram Hospital, Tehran, Iran. Participants were randomly divided into two groups. The intervention group received 50,000 IU vitamin D3 weekly and the control group received a placebo for 9 weeks. All patients received Mebeverine 135 mg twice a day besides supplementation. The IBS Severity Score System (IBS-SSS), serum 25(OH) vitamin D3, CRH, and IL-6 were measured before and after interventions. RESULTS: Seventy-four patients completed the study. The severity of IBS symptoms (p < 0.01) and IL-6 (p = 0.02) decreased significantly in the intervention group as compared to the control group, but there was no significant difference in the serum level of CRH. Also, in the treatment group, IBS-SSS and IL-6 were significantly reduced at the end of the study from baseline (p < 0.01 and p < 0.03, respectively). CONCLUSION: Our findings indicate that vitamin D3 supplementation can modulate the serum level of CRH and IL-6 and can improve symptoms in IBS-D patients. Vitamin D3 supplementation should be considered in IBS-D patients who suffer from vitamin D deficiency and/or insufficiency.

The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment.

BACKGROUND AND AIM: Many of the treatment regimens available for hepatitis C include sofosbuvir. Unfortunately, sofosbuvir has not been recommended for use in patients with severe renal impairment leaving these group of patients with very few options. Nevertheless, there are many reports in which these patients have been treated with sofosbuvir-containing regiments without important adverse events. This study aims at determining the safety and effectiveness of a sofosbuvir-based treatment in patients with severe renal impairment, including those on hemodialysis. METHOD: We enrolled subjects with hepatitis C and estimated glomerular filtration rate under ml/min/1.73m2 from 13 centers in Iran. Patients were treated for 12 weeks with a single daily pill containing 400-mg sofosbuvir and 60-mg daclatasvir. Patients with cirrhosis were treated for 24 weeks. Response to treatment was evaluated 12 weeks after end of treatment (sustained viral response [SVR]). ClinicalTrials.gov identifier: NCT03063879. RESULTS: A total of 103 patients were enrolled from 13 centers. Seventy-five patients were on hemodialysis. Thirty-nine had cirrhosis and eight were decompensated. Fifty-three were Genotype 1, and 27 Genotype 3. Twenty-seven patients had history of previous failed interferon-based treatment. Three patients died in which cause of death was not related to treatment. Six patients were lost to follow-up. The remaining 94 patients all achieved SVR. No adverse events leading to discontinuation of medicine was observed. CONCLUSIONS: The combination of sofosbuvir and daclatasvir is an effective and safe treatment for patients infected with all genotypes of hepatitis C who have severe renal impairment, including patients on hemodialysis.