Effects of a psychoeducation intervention on fear and anxiety about surgery: randomized trial in patients undergoing coronary artery bypass grafting.

The aim of this study was to examine the impact of a brief psychoeducation group intervention on fear and anxiety in patients undergoing the coronary artery bypass grafting (CABG). Sixty consecutive patients undergoing CABG for the first time were recruited for a clinical trial and randomized into two groups. The control group received routine care. The study group received a brief psychoeducation group intervention combined with routine care. The psychoeducation session consisted of a discussion of fear and anxiety in a psychotherapeutic atmosphere and relaxation techniques. Fear was scored with the Bypass Grafting Fear Scale (BGFS) and anxiety was scored with the Spielberger State Inventory (STAI) Questionnaire. The BGFS and the STAI were given to the patients the day after hospital admission and a day before the operation to measure fear and anxiety. Fear scores decreased in the psychoeducation group. Of the 29 patients treated with psychoeducation, the mean (SD) fear score decreased from 4.6 (1.7) at baseline to 2.8 (1.2) before the operation (p < .001). In the 31 patients who received routine care, there was a nonsignificant trend from 3.7 (1.9) to 4.1 (2.1) (p > .05). The mean difference in fear score before the operation was significantly lower in the psychoeducation group than the routine care group (mean difference -1.3; 95% CI, -2.1, -.2; p < .05). There were no differences in anxiety scores before the operation between the psychoeducation and routine care groups. In patients undergoing CABG, adding psychoeducation to routine care had a significant positive effect on fear but not on anxiety scores. A larger study of psychoeducation in these patients is warranted to assess the efficacy of this intervention in greater detail.

Mesenchymal Stromal Cell Therapy Improves Refractory Perianal Fistula in Crohn's Disease: Case Series Clinical Interventional Study.

Objective: Perianal fistulas in Crohn's disease (CD) are the main challenges in inflammatory bowel diseases (IBDs). Some of the fistulas are refractory to any therapeutic strategy. The aim of this study was to evaluate the therapeutic effects of mesenchymal stromal cells (MSCs) as a novel promising modality for the treatment of fistulizing CD. Materials and Methods: This case series clinical interventional study was conducted from 2014 to 2017 at Shariati Hospital, an IBD referral center in Tehran, Iran. Refractory adult patients with CD who had draining perianal fistulas were enrolled in this study. All patients were examined by a colorectal surgeon and the fistula imaging studies were performed by pelvic magnetic resonance imaging (MRI). After autologous bone marrow (BM) aspiration and MSCs isolation, the cells were cultured and passaged under current good manufacturing practice (cGMP) conditions. Four intra-fistula injections of cells, each containing 40×106 MSCs suspended in fibrin glue, were administered by an expert surgeon every 4 weeks. Procedure safety, feasibility and closure of the perianal fistulas at week 24 were assessed. Clinical examination and MRI findings were considered as the primary end points. Results: In total, 5 patients (2 males and 3 females) were enrolled in this study. No adverse events were observed during the six-month follow-up in these patients. Both the Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI) scores decreased in all patients after cell injections and one patient achieved complete remission with closure of fistulas, discontinuation of fistula discharge, and closure of the external opening. Conclusion: Local injection of MSCs combined with fibrin glue is potentially a safe and effective therapeutic approach for complex perianal fistulas in patients with CD.

Survival features, prognostic factors, and determinants of diagnosis and treatment among Iranian patients with pancreatic cancer, a prospective study.

OBJECTIVES: Investigating the survival features, and determinants of treatment and stage at presentation in Iran. METHODS: 461 patients with pancreatic ductal adenocarcinoma (PC) were prospectively enrolled from Shariati hospital, Tehran, Iran, between 2011-2018. All patients underwent endoscopic ultrasonography, computed tomography scanning, and physical examination. Validated questionnaire was completed for the participants and all were actively followed on monthly basis. RESULTS: Median survival time was 6.5 months, and 1-, and 5-year survival rates were 26.2%, and 1.5%. Patients who were older (p<0.001), illiterate (p = 0.004), unmarried (p = 0.003), rural inhabitant (p = 0.013), opium user (p = 0.039), and had lower body mass index (BMI) (p = 0.002) had lower overall survival. Tumors located in the head of pancreas were more commonly diagnosed at lower stages (p<0.001). Only 10.4% of patients underwent surgery who were more commonly educated (p<0.001), married (p = 0.005), had a tumor located in the head of pancreas (p = 0.016), and were diagnosed at lower stages (p<0.001). After adjustment for potential confounders and risk factors, rural inhabitance (HR: 1.33 (95% CI: 1.01-1.74)), having more symptoms (HR for each increasing symptom: 1.06 (1.02-1.11)), using opium (HR: 1.51 (1.04-2.20)), having a tumor located in the body of pancreas (HR: 1.33 (1.02-1.75)), and having an advanced tumor stage (HR: 2.07 (1.34-3.19)) remained significantly associated with increased risk of mortality. After the adjusting for potential confounders, we did not find significant relationships between smoking, alcohol intake, and BMI with the risk of death among patients with pancreatic cancer. CONCLUSIONS: Iranian patients with PC have very poor long-term survival. Besides tumor's stage and location, socioeconomic disparities could affect the probabilities of receiving treatment and/or survival in these patients. Opium use is an independent risk factor for mortality among PC patients in Iran.

Role of Th1/Th2 cells and related cytokines in autoimmune hepatitis.

BACKGROUND/AIMS: Dysregulation of T cell response is thought to play an important role in the immunopathogenesis of autoimmune hepatitis. However, no consensus has yet been reached regarding the implications of a distinct T cell subset in the pathogenesis of this progressive liver disease. Therefore, T-bet and GATA-3 expression was examined in patients with autoimmune hepatitis (AIH) and in healthy controls. Moreover, the profile of Th1 (IFN-γ) and Th2 (IL-4) cytokine gene expression was analyzed. MATERIALS AND METHODS: Levels of mRNA transcripts were measured in peripheral blood mononuclear cells (PBMCs) using a two-step reverse transcription quantitative real-time polymerase chain reaction with SYBR Green. RESULTS: T-bet and IFN-γ mRNA expression was significantly higher in AIH patients compared to healthy controls (p<0.05), whereas no differences were observed for either GATA-3 or IL-4 mRNA expression (p>0.05). CONCLUSION: Alterations in the Th1/Th2 cell balance may be responsible for both disease progression and the resulting complications.

Solid Pseudopapillary Neoplasm of Pancreas; A Case Series and Review Literature.

BACKGROUND Information regarding solid pseudopapillary neoplasm (SPN) of the pancreas is limited in Iran. We aimed to review the clinicocytopathological features and follow-up of patients with SPN of pancreas who were diagnosed in a single center in Iran. METHODS Seven patients with SPN of the pancreas were diagnosed during January 2010 to March 2015 at the Digestive Disease Research Institute of Tehran University of Medical Sciences. The patients were reviewed prospectively. RESULTS Six out of the 7 patients were female and the mean age of all the patients was 29.4 years ranging from 15 to 61 years. The most common clinical presentation was nonspecific abdominal pain (N=6). The tumors were located mostly in head and neck of the pancreas. SPN was diagnosed in all patients by fine needle aspiration through endosonography (EUS-FNA). All patients underwent surgery. Histological findings of surgical tissues were consistent with EUS-FNA. The postoperative follow-up period of about 14 months was uneventful. CONCLUSION SPN of the pancreas is a rare pancreatic tumor which affects primarily young women. EUS-guided FNA could play an important role in preoperative diagnosis of SPN of the pancreas.

Repeated Intraportal Injection of Mesenchymal Stem Cells in Combination with Pioglitazone in Patients with Compensated Cirrhosis: A Clinical Report of Two Cases.

BACKGROUND: Transplantation of mesenchymal stem cells (MSCs) in combination with pioglitazone, an agonist of peroxisome proliferator-activated receptor-γ (PPAR-γ), can reduce liver fibrosis in models of liver injury. In this study, we conducted a pilot study of intraportal infusion of autologous MSCs in combination with pioglitazone to assess safety, feasibility, and effectiveness in patients with compensated cirrhosis. METHODS: Two patients with compensated cirrhosis were enrolled in this study. Intraportal autologous bone marrow-derived MSCs were transplanted twice (6 months interval) to the patients. Meanwhile, 30 mg/day pioglitazone was prescribed for 12 months.  Patients were assessed at baseline and months 1, 3, 6, and 12 post-infusion. RESULTS: Procedural complications or any major adverse effects did not occur in this pilot study.  The patients' clinical conditions remained stable with no evidence of deterioration during the course of the study. A transient improvement in the Model for End-Stage Liver Disease (MELD) score was observed at month 3 post-infusion in one patient, which eventually returned to baseline at month 12. CONCLUSION: The combination of pioglitazone with MSCs is safe and feasible. The data justify further study of the combination therapy in cirrhotic patients.

Opium use, cigarette smoking, and alcohol consumption in relation to pancreatic cancer.

BACKGROUND AND AIMS: Although several studies have suggested opium as a risk factor for cancers of the esophagus, stomach, larynx, lung, and bladder, no previous study has examined the association of opium with pancreatic cancer. We aimed to study the association between opium use and risk of pancreatic cancer in Iran, using a case-control design. We also studied the association of cigarette smoking and alcohol consumption with pancreatic cancer, for which little information was available from this population. METHODS: Cases and controls were selected from patients who were referred to 4 endoscopic ultrasound centers in Tehran, Iran. We recruited 316 histopathologically (all adenocarcinoma) and 41 clinically diagnosed incident cases of pancreatic cancer, as well as 328 controls from those with a normal pancreas in enodosonography from January 2011 to January 2015. We used logistic regression models to calculate odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: After adjustment for potential confounders, opium use (OR 1.91; 95% CI 1.06-3.43) and alcohol consumption (OR 4.16; 95% CI 1.86-9.31) were significantly associated with an increased risk of pancreatic cancer. We did not find an association between ever tobacco smoking and pancreatic cancer risk (OR 0.93; 95% CI 0.62-1.39). CONCLUSION: In our study, opium use and alcohol consumption were associated with an increased risk of pancreatic cancer, whereas cigarette smoking was not.

Intraportal Infusion of Bone Marrow Mononuclear or CD133+ Cells in Patients With Decompensated Cirrhosis: A Double-Blind Randomized Controlled Trial.

UNLABELLED: The present study assessed the effects of intraportal infusions of autologous bone marrow-derived mononuclear cells (MNCs) and/or CD133+ cells on liver function in patients with decompensated cirrhosis. We randomly assigned 27 eligible patients to a placebo, MNCs, and/or CD133+ cells. Cell infusions were performed at baseline and month 3. We considered the absolute changes in the Model for End-Stage Liver Disease (MELD) scores at months 3 and 6 after infusion as the primary outcome. The participants and those who assessed the outcomes were unaware of the treatment intervention assignments. After 6 months, 9 patients were excluded because of liver transplantation (n=3), hepatocellular carcinoma (n=1), loss to follow-up (n=3), and death (n=2). The final analysis included 4 patients from the CD133+ group, 8 from the MNC group, and 6 from the placebo group. No improvement was seen in the MELD score at month 6 using either CD133+ cells or MNC infusions compared with placebo. However, at month 3 after infusion, a trend was seen toward a higher mean absolute change in the MELD score in patients who had received CD133+ cells compared with placebo (-2.00±1.87 vs. -0.13±1.46; p=.08). No significant adverse events occurred in the present study. A transient improvement in the MELD score was observed in subjects treated with CD133+ cells but not in the MNC or placebo group. Although the study was not powered to make definitive conclusions, the data justify further study of CD133+ therapy in cirrhotic patients. SIGNIFICANCE: Cell therapy is a new approach in liver disease. Several clinical experiments have been reported on the safety of bone marrow-derived stem cells to treat liver disorders. However, the effectiveness of these approaches in the long-term follow-ups of patients initiated controversial discussions among the scientific community. A double-blind randomized controlled trial was designed to address this concern scientifically. A transient improvement in the patients' signs occurred; however, for a sustainable result, more work is needed. The results of multiple administrations of cells reported in the present study can be compared with the results from other single-injection studies.

Clinical and pathological features of non-functional neuroendocrine tumors of pancreas: a report from iran.

BACKGROUND Pancreatic neuroendocrine tumors (PNETs) are rare tumors with variable malignant potential, prognosis, and survival. We aimed to assess the characteristics of patients with non- functional PNET in our hospital. METHODS From Nov 2010 to Nov 2013 , all patients who came to endosonography unit of Shariati hospital , Tehran , Iran , and had pancreatic lesions were assessed . Tumor samples were obtained through fine needle aspiration. Various characteristics of the non- functional PNET were recorded and patients were followed up to three years. RESULTS Twenty eight non func-PNET cases, aged 37-72 years were identified, 15 (53.6%) of whom were men. Fifteen (53.6%) tumors were located in the head and 5(17.8%) in the body of the pancreas. The mean tumor size was 3.9 Cm and 10.7% , 28.6%, 32.1%, and 28.6% of the patients were at stages I, II, III and IV, respectively. Of the patients, 12 (43%) underwent surgery, 3 (10.7%) received chemotherapy, and 13 (46.4%) received no treatment. During the mean follow-up of 16 months, the disease had progressed in 3 (10.7%) patients and 10 (35.7%) had died. In univariate analysis, tumor size>3Cm and Ki-67>20% were correlated with survival rate but not in multivariate analysis. CONCLUSION Iranian patients with non- functional PNET present similar characteristics to world patients. There is a need to establish efficacy of tumor samples which are obtaining through fine needle aspiration for assessing tumor grading.

Squamous cell carcinoma of the pancreas.

Squamous cell carcinoma (SCC) of the pancreas is a controversial entity of uncertain origin, as the pancreas is entirely devoid of squamous cells. Cases of pancreatic carcinomas that exhibit primary squamous morphology are rarely described in the literature. We report a case of primary SCC of the pancreas in a 66-year-old woman with complaints of epigastric pain of five months duration. Imaging studies demonstrated a solid tumor in the body of the pancreas that invaded the superior mesenteric (SMA) and celiac arteries, as well as regional lymph nodes. Cytological examination of an endosonography-guided fine needle aspiration (EUS-FNA) specimen confirmed the diagnosis of well-differentiated SCC of the pancreas. On the basis of diagnosis and examinations prior to chemotherapy, we did not detect any SCC lesions that might have metastasized to the pancreas. Primary SCC of the pancreas is a rare entity that comprises 0.05% of all exocrine pancreatic carcinomas. The clinical profile and biological behavior of pancreas SCC are similar to typical pancreatic ductal adenocarcinomas.

Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis: Interim Analysis Report of a Randomized Controlled Trial.

BACKGROUND: Corticosteroids are used to induce remission in auto-immune hepatitis.They are not universally effective; therefore, alternative treatments are needed.In this study Cysclosporine-A has been compared with prednisolone as an alternativetreatment in a randomized controlled trial. This paper is an interimanalysis of an ongoing clinical trial. METHODS: Sixteen years and older consenting patients were enrolled. Group-A receivedprednisolone and group-B cyclosporine-A according to a preset protocoland followed at regular intervals for 48 weeks. Final assessment was doneat week 48. Primary outcome was response rate as defined below. "Completeresponse" was defined as achieving AST and ALT in the normal range andabsence of any clinical signs of deterioration, and partial response was definedas a decrease in AST and ALT by less than half of their original values but notto within normal limit. Non-responding ones at week eight were switched tothe other arm. RESULTS: Thirty-nine patients were enrolled (24 group-A, 9 male). Mean AST andALT at baseline were higher in group-B, but other variables were comparable.At week 12, 34.8% and 64.3% of group-A and B had achieved AST and ALTin the normal range (less than 40 IU/L) respectively (p=0.081). Correspondingfigures at week 48 were 50.0% and 47.6% (p=0.62 & 0.48 respectively).At week 12, 86.9% and 85.7% of patients had AST and ALT levels less thantwice upper normal limit in groups-A and B respectively (p=0.54 & 0.42).Corresponding figures at week 48 were 90.0% for both groups. There was onetreatment failure in group-B which did not respond to prednisolone either.Serious adverse events (death and liver transplantation) occurred in group-Aonly. Serum creatinine did not change during the study period in either group. CONCLUSION: According to our data, Cyclosporine-A is as effective as prednisolone forinduction of remission in AIH. Adverse events and serious adverse events weremore common with prednisolone.

Probiotic vs. Placebo in Irritable Bowel Syndrome:A Randomized Controlled Trial.

BACKGROUND: This study assesses the potential effect of Lactobacillus reuteri as a single strain probiotic preparation (Biogaia®) on irritable bowel syndrome (IBS). METHODS: Patients diagnosed with IBS who fulfilled Rome III criteria and consented to participate in this study were randomized to receive either the probiotic or an identical placebo once daily for four weeks. Patients used a questionnaire to record any symptoms and adverse reactions over a one-week run-in period and during the final two weeks of intervention. For each group, we calculated the differences between mean scores of the variables and compared the results between groups. RESULTS: Frequency of defecation increased in the Biogaia® group and decreased in the placebo group meaningfully. But There were no significant difference in the two groups in other terms of bloating, sense of urgency for defecation, abdominal pain, stool shape, quality of defecation, sense of incomplete evacuation, and treatment satisfaction. CONCLUSION: The frequency of defecation increased in the Biogaia® group and decreased in the placebo group, however this study did not classify patients according to diarrhea or constipated subgroups, the efficacy of this drug is not clear. Hence Lactobacillus reuteri was not better than placebo in controlling IBS symptoms in this study. However, considering the significant placebo effect in IBS patients, it may be necessary to conduct studies with larger numbers of participants to better assess the possible beneficial effects of Biogaia.