Outcomes of COVID-19 in Patients with Inflammatory Bowel Disease: Comparison with Household Members and the Role of IBD Medications.

BACKGROUND: Most data on the effect of inflammatory bowel disease (IBD) and its treatments on coronavirus disease 2019 (COVID-19) outcomes have not had non-IBD comparators. Hence, we aimed to describe COVID-19 outcomes in IBD compared to non-IBD patients. METHODS: We conducted a prospective cohort study of registered IBD patients with confirmed COVID-19 from six provinces in Iran from February to April 2020. Proven COVID-19 patients were followed up at four weeks and the frequency of outcomes was assessed. Multivariable logistic regression was used to assess associations between demographics, clinical characteristics and COVID-19 outcomes. RESULTS: Overall, 2159 IBD patients and 4721 household members were enrolled, with 84 (3.9%) and 49 (1.1%) participants having confirmed COVID-19, respectively. Household spread of COVID-19 was not common in this cohort (1.2%). While hospitalization was significantly more frequent in IBD patients compared with non-IBD household members (27.1% vs. 6.0%, P=0.002), there was no significant difference in the frequency of severe cases. Age and presence of IBD were positively associated with hospitalization in IBD compared with non-IBD household members (OR: 1.06, 95% CI: 1.03-1.10; OR: 5.7, 95% CI: 2.02- 16.07, respectively). Age, presence of new gastrointestinal symptoms, and 5-aminosalicylic acid (5-ASA) use were associated with higher hospitalization rate in IBD patients (OR: 1.13, 95% CI: 1.05-1.23; OR: 6.49, 95% CI: 1.87-22.54; OR: 6.22, 95% CI: 1.90-20.36, respectively). Anti-tumor necrosis factor (TNF) was not associated with more severe outcomes. CONCLUSION: Age, presence of new gastrointestinal symptoms and use of 5-ASA were associated with increased hospitalization rate among IBD patients, while anti-TNF therapy had no statistical association.

Efficacy of Common Bile Duct Stenting on the Reduction in Gallstone Migration and Symptoms Recurrence in Patients with Biliary Pancreatitis Who Were Candidates for Delayed Cholecystectomy.

BACKGROUND: In patients with severe biliary pancreatitis, delayed cholecystectomy associated with a high risk of recurrence is recommended. The current study aimed to evaluate the effect of common bile duct (CBD) stenting on reducing gallstones migration and recurrence of symptoms in patients with pancreatitis and delayed cholecystectomy candidates. METHODS: To this purpose, the randomized, controlled clinical trial was performed on 40 patients with biliary pancreatitis who were candidates for delayed cholecystectomy. Patients were randomly divided into two groups of A and B that underwent CBD stenting after ERCP and received endoscopic treatment without stenting, respectively. A checklist recorded demographics and complications. Group A was followed up after four weeks to remove the stent and record the complications. Group B underwent MRCP to examine the migration of new gallstones as well as the complications. RESULTS: Of the 40 patients, 20 subjects (11 males and 9 females) were allocated to each group, matched for demographic variables. In the one-month follow-up, only one subject in group A manifested symptoms of gallstone migration and recurrence, while in group B, recurrence was observed in 6 patients (P = 0.037). There was no significant difference in the success rate of ERCP and the incidence of complications between the two groups. CONCLUSION: CBD stenting in patients with biliary pancreatitis and gallstone could reduce the risk of recurrence and remigration of gallstones in delayed cholecystectomy cases.

Susceptibility of Patients with Inflammatory Bowel Disease to COVID-19 Compared with Their Households.

BACKGROUND: Immunosuppressive agents used in the treatment of inflammatory bowel diseases (IBDs) could potentially increase the risk of coronavirus disease 2019 (COVID-19). We aimed to compare COVID-19 frequency in patients with IBD with their households and identify the related risk factors. METHODS: Firstly, a multi-centered, observational study on 2110 patients with IBD and 2110 age-matched household members was conducted to compare COVID-19 frequency. Secondly, the data of patients with IBD and COVID-19 who had called the COVID-19 hotline were added. Multivariable logistic regression was used to evaluate the effect of age, type and severity of IBD, the number of comorbidities, and medications on the frequency of COVID-19 among the patients with IBD. RESULTS: The prevalence of COVID-19 in patients with IBD and household groups was similar (34 [1.61%] versus 35 [1.65%]; P = 0.995). The prevalence of COVID-19 increased from 2.1% to 7.1% in those with three or more comorbidities (P = 0.015) and it was significantly higher in those with severe IBD (P = 0.026). The multivariable analysis only showed a significant association with anti-TNF monotherapy (OR: 2.5, CI: 0.97-6.71, P = 0.05), and other medications were not associated with COVID-19. CONCLUSION: The prevalence of COVID-19 in patients with IBD was similar to the household members. Only patients with IBD receiving anti-TNF monotherapy had a higher risk of COVID-19 susceptibility. This finding could be attributed to the higher exposure to the virus during administration in health care facilities.

Production of SARS-CoV-2 Antibodies and Emergence of the Clinical Symptoms of COVID-19.

Coronavirus disease 2019 (COVID-19) is a worldwide public health problem that has attracted much attention due to its clinical findings. Measurement of IgG and IgM antibodies is of great importance for researchers and it will help to develop a new diagnostic and therapeutic method in clinical care. In this cross-sectional study, we aim to measure the IgG and IgM antibody levels in 401 suspected COVID-19 volunteers. We also measure the time duration for the appearance of IgG and IgM antibodies from the onset of symptoms to sampling time. Of 401 participants enrolled in the study, 255 (63.59%) were healthy, 79 (19.70%) were a carrier, 59 (14.71%) were cured and 8 (1.99%) were borderline. Of 142 subjects diagnosed with COVID-19, 41 (28.87%) presented with gastrointestinal (GI) symptoms, 83 (58.45%) had no GI symptoms, and 18 (12.68%) were asymptomatic. According to our findings, the measurement of IgG and IgM antibodies will provide the tool for the diagnosis of COVID-19 and significantly boost research into novel diagnostic and therapeutic approaches.

Hepatic Involvement as Hyperbilirubinemia in Patients with COVID-19: Case Series from Iran.

BACKGROUND: After the spread of novel coronavirus disease 2019 (COVID-19) from Wuhan to Iran, gastroenterology clinics, was faced with a large number of patients who were suspected of being infected with the SARS-CoV-2. Among refereed patient, the incidence of pure hyperbilirubinemia as rare gastrointestinal (GI) symptoms was obvious. METHODS: In this case series, we have reported the clinical data in details for patients with COVID-19 who have been admitted to the Shahid Beheshti Hospital in Qom city, from 3 March to 3 August 2020. COVID infection, be confirmed by using real-time reverse-transcriptase polymerase chain reaction (rRT-PCR) and chest computed tomography (CT) scan, as well. RESULTS: According to the clinical findings, pure hyperbilirubinemia may consider as rare gastrointestinal (GI) symptom of COVID-19. However, it is possible that the other GI enzymes values fall in to the normal range. CONCLUSION: In some infected patients, GI physicians may face hepatic involvement as pure hyperbilirubinemia. At the age of COVID-19 crisis, all GI physicians should be aware of the possible occurrence of hepatic involvement as an important prognosis of COVID pneumonia and it should be exactly addressed in new referred patients to GI clinic.

Adding ursodeoxycholic acid to the endoscopic treatment and common bile duct stenting for large and multiple biliary stones: Will it improve the outcomes?

BACKGROUND: The role of common bile duct (CBD) stenting in the establishment of bile stream in the elderly patients and the ones who are not good candidates for surgery due to not responding to treatments was well documented in previous studies. The current study aimed at investigating the effect of adding Ursodeoxycholic acid (UDCA) to CBD stenting alone in order to reduce the size of large and multiple CBD stones. METHODS: Clinical outcomes including success rates in CBD stones clearance, incidence of pancreatitis, perforation, bleeding, as well as, decrease in size of stones and liver enzymes after a two-month period were assessed in the UDCA + CBD stenting group. RESULTS: A total of 64 patients referring to Shahid Beheshti Hospital in Qom, Iran with multiple or large CBD stones (above three or larger than 15 mm) received standard endoscopic therapies and UDCA + CBD stenting (group B) and controls only received standard endoscopic therapies with only CBD stenting (group A). The mean reduction in the size of stones in group B was significantly higher than that of group A (3.22 ± 1.31 vs 4.09 ± 1.87 mm) (p = 0.034). There was no difference in the incidence rate of complications including pancreatitis, cholangitis, bleeding, and perforation between the two groups (P > 0.05). CONCLUSION: Adding UDCA to CBD stenting, due to decrease in the stone size and subsequently facilitation of the stones outlet, can be considered as the first-line treatment for patients with large and multiple CBD stones. Also, in the cases with large or multi stones may be effective in reducing size and subsequently stone retrieval. Trial registry The study protocol was approved by the Ethics Committee of Qom University of Medical Sciences (ethical code: IR.MUQ.REC.1397.075); the study was also registered in the Iranian Registry of Clinical Trials (No. IRCT20161205031252N8). This study adheres to CONSORT guidelines.

The COVID-19 Outbreak in Iran; The First Patient with a Definite Diagnosis.

The novel coronavirus, formerly named as 2019 novel coronavirus (2019-nCov) caused a rapidly spreading epidemic of severe acute respiratory syndrome (SARS) in Wuhan, China and thereafter, progressed globally to form a pandemic of coronavirus disease 2019 (COVID-19) in numerous countries; and now confirmed cases are reported from several provinces of Iran. Now various medical centers, clinicians and researchers around the world share their data and experiences about COVID-19 in order to participate in the global attempt of controlling the pandemic. The current report investigates the clinical presentations and paraclinical findings of the first confirmed cases and mortalities in the initiation of the outbreak of COVID-19 in Iran.

A Supporting System for Management of Patients with Inflammatory Bowel Disease during COVID-19 Outbreak: Iranian Experience-Study Protocol.

BACKGROUND The COVID-19 pandemic has affected the health care infrastructure dramatically, with abundant resources necessarily being redirected to COVID-19 patients and their care. Also, patients with chronic diseases like inflammatory bowel disease (IBD) may be affected in several ways during this pandemic. METHODS We used the Iranian registry of Crohn's and colitis (IRCC) infrastructure. We called and sent messages to follow-up and support the care of all registered patients. Besides, we prepared and distributed educational materials for these patients and physicians to reduce the risk of COVID-19 infection. We risk-stratified them and prepared outpatient clinics and hospitalization guidance for IBD patients. RESULTS Of 13165 Iranian patients with IBD, 51 have been diagnosed as having COVID-19. IBD patients made 1920 hotline calls. Among the patients with suspicious presentations, 14 COVID-19 infections were diagnosed. Additionally, 1782 patients with IBD from five provinces actively phone-called among whom 28 definite cases were diagnosed. CONCLUSION IBD patients' follow-up could help in diagnosing the affected IBD patients with COVID-19. Additionally, the performance of protective actions and preparing the patients and physicians for decisive proceedings are the principles of protection of IBD patients.

Atorvastatin in combination with conventional antimicrobial treatment of Helicobacter pylori eradication: A randomized controlled clinical trial.

BACKGROUND AND AIM: Helicobacter pylori is one of the main causes of digestive diseases, which is difficult to treat and requires the administration of several antimicrobial agents. Considering the anti-inflammatory and antibacterial effect of atorvastatin, the present study aimed at adding this agent to a four-drug regimen in order to eradicate H. pylori. METHODS: A total of 220 patients with H. pylori infection were included in the current randomized controlled clinical trial. In the current study, 110 patients in the control group received a 14-day regimen of amoxicillin, clarithromycin, bismuth, and esomeprazole, and 110 patients in the intervention group received 40 mg of atorvastatin daily plus the antibiotic regimen for 14 weeks. The treatment results were evaluated 1 month later using H. pylori stool antigen test. Data were collected using checklist and analyzed using chi-squared and Fisher's exact tests with spss version 18. RESULTS: Helicobacter pylori eradication rate in the intervention and control groups was 78.18% and 65.45%, respectively (P = 0.025), and there was a significant difference in terms of non-ulcer dyspepsia between the groups (P = 0.049), but there was no significant difference in age, gender, and body mass index between the two groups (P < 0.05). CONCLUSION: The present study results showed that adding atorvastatin to the four-drug regimen of omeprazole, clarithromycin, bismuth, and amoxicillin is effective in the eradication of H. pylori. Also, the addition of atorvastatin to H. pylori eradication therapy is more effective in patients with non-ulcer dyspepsia.

Consequences of Stenting and Endoscopic Papillary Balloon Dilatation in Treatment of Large and Multiple Common Bile Duct Stones.

BACKGROUND Although stenting for the treatment of large and multiple common bile duct stones has been acceptable to everyone, its efficacy and outcome have not been studied in comparison with other endoscopic procedures. The purpose of this study was to compare the consequences of stenting and endoscopic papilla balloon dilatation for the treatment of large and multiple common bile duct stones. METHODS In a double-blind clinical trial, of 431 patients with bile duct stones referred to the treatment center, 64 patients with multiple common bile duct stones ( ≥ 3) and more than 15 cm were selected for the study, then by random allocation rule the participants were allocated in two groups. They were entered into two different endoscopic papillary balloon dilatation (EPBD) and common bile ducts stenting treatments so that both procedures were performed by a person. Both groups were assessed from the point of views therapeutic outcomes such as duct cleaning, pancreatitis, isolated pain, and duct rupture. Data were collected by a self-made questionnaire that was used before and after the procedure to obtain the needed information. Then data were analyzed using SPSS software version 22 and descriptive and analytical tests were used as appropriated. RESULTS Although the duct cleaning and the complete removal of the stones in the stenting treatment procedure was 93.8%, and in EPBD was 78.3%, no significant difference was observed between the two groups (p = 0.14). Pancreatitis significantly increased after the first and second endoscopic retrograde cholangiopancreatography (ERCP) in the stent group compared with EPBD (p = 0.02). Also, the most frequent cases of isolated pain were in the endoscopic group EPBD (p = 0.0). However, the occurrence of perforation after first ERCP and EPBD was zero, but in the second stage of ERCP, 3.3% of the patients had perforations (p = 0.99). The results indicated that the shape of the stone (circular and angled) was not effective in the result of treatment in the two groups. CONCLUSION The results of this study indicated that in case of experience and skill in conducting the ERCP, common bile duct stenting is still the first line of treatment for large and multiple stones of the common bile ducts.

Prevalence of Anesthetic and Gastrointestinal Complications of Endoscopic Retrograde Cholangiopancreatography.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic method for treatment of many biliary diseases. With respect to rapid recovery and more patient comfort, this procedure is currently performed under light general anesthesia (GA) or conscious sedation. OBJECTIVES: The current study aimed to clarify that intravenous sedation or light general anesthesia can be performed without great fear of anesthesia related complications in ERCP patients and sedative doses of propofol can be used safely in outpatient settings under the supervision of an expert anesthesiologist. METHODS: This is a cross-sectional study on 1023 ERCP patients under light GA during 2014 - 2018 in Qom, Shahid Beheshti Hospital. Data were collected by a checklist and were analyzed by using chi-square test in SPSS V.22. RESULTS: From 1023 patients, 501 (48.97 %) were male and 522 (51.03 %) were female with a mean age of 47.2 ± 6.7 years. The most common finding in ERCP was choledocholithiasis (76.15 %). The most common complication was hemodynamic instability (37.01 %) followed by desaturation (11.65 %) both of them ware anesthesia related. Prevalence of GI (gastrointestinal) related complications was 13.39 %. The most common GI related complications were pancreatitis (7.92 %) and bleeding (3.32 %). Total mortality rate was 0.88 %. CONCLUSIONS: ERCP-related complications are inevitable but can be controlled by early diagnosis and clinical experience. Severe complications and high risk patients may increase the mortality and morbidity of the procedure. Anesthesia related complications are more frequent than GI related unwanted events. Fortunately, the most common anesthesia related complications are readily manageable and are minor in nature when an expert anesthesiologist is present in the scene. Close monitoring of the patient's vital signs should be the mainstay of the safe procedure.

A High Serum-Ascites Albumin Gradient and Mediastinal Fibrosarcoma: A Case Report.

Accumulation of free fluid in the peritoneal cavity is called ascites. The first step in identifying its etiology is to determine the serum-ascites albumin gradient (SAAG). According to this parameter, a high SAAG is regarded as a gradient greater than 1.1 g/dL. This condition has some differential diagnoses such as liver cirrhosis, Budd-Chiari syndrome, heart failure, and idiopathic portal fibrosis. In the present article, we present a young man with abdominal distention due to a high SAAG. Further evaluation of the abdominal and thoracic cavity revealed a mass in the posterior mediastinum, which had compressed the inferior vena cava and left atrium and led to Budd-Chiari syndrome. Evaluation of the biopsy sample showed fibrosarcoma. Mediastinal fibrosarcomas, though rare, should be considered in the differential diagnosis of mediastinal masses.

Mesalazine Has No Effect on Mucosal Immune Biomarkers in Patients with Diarrhea-Dominant Irritable Bowel Syndrome Referred to Shariati Hospital: A Randomized Double-Blind, Placebo-Controlled Trial.

BACKGROUND Intestinal mast cells may cause gastrointestinal symptoms in patients with diarrhea-dominant irritable bowel syndrome (IBS). The objective of this study was to determine the effect of mesalazine on the number of lamina propria mast cells and clinical manifestations of patients with diarrhea-dominant IBS referred to Shariati Hospital affiliated to Tehran University of Medical Sciences. METHODS This was a randomized placebo-controlled double-blind trial conducted on 49 patients with diarrhea-dominant IBS. The patients were randomly assigned to one of the experiment or control groups. The patients in experiment group took 2400 mg mesalazine daily in three divided doses for 8 weeks and the patient in control group took placebo on the same basis. Our first targeted outcome was an assigned downturn of mast cells number to the safe colonic baseline and the next one was a marked palliation of disease symptoms. Data were analyzed conforming intention-to-treat method. We used MANCOVA test to compare our both assigned outcomes in the two groups. We also compared the data with baseline values in both groups.All statistical tests were performed at the significance level of 0.05. RESULTS There was no significant difference between Mesalazine and placebo groups regarding the number of mast cells (p value=0.396), abdominal pain (p value=0.054), bloating (p value=0.365), defecation urgency (p value=0.212), and defecation frequency (p value=0.702). CONCLUSION Mesalazine had no significant effect either on the number of mast cells or on the severity of disease symptoms. This finding seems to be inconsistent with the hypothesis indicating immune mechanisms as potential therapeutic targets in IBS. The possible difference in this effect of Mesalazine should be evaluated in further studies among populations varying in race, ethnic, and geographical characteristics.

Nonadherence to Medication in Inflammatory Bowel Disease: Rate and Reasons.

BACKGROUND This study is the first study to evaluate the nonadherence rate and reasons of same patient with inflammatory bowel disease (IBD) in Iran. METHODS During 9 months, 500 patients with IBD were enrolled in the study. Patients were interviewed about their nonadherence behaviors. Factor analysis was used to analyze the collected answers. RESULTS The overall rate of nonadherence was 33.3% (27.6% intentional nonadherence and 5.7% unintentional nonadherence). 33.6% of the patients had at least one relapse after discontinuing treatment. The most frequent reason for intentional nonadherence was discontinuing the treatment after recovering from symptoms (42.7%). The most frequent reason for unintentional nonadherence was forgetfulness (5.2%). 19.8% of the patients did not visit their gastroenterologist on time and they purchased drugs from the drugstore. These patients reported that their clinics were too far and difficult to access. There was no significant relationship between nonadherence and demographic variables. CONCLUSION Multiple reasons are suggested as factors of medication nonadherence and they seem to be different among different populations. Determining these possible reasons, could lead to finding suitable strategies to overcome or reduce them.