Background and Aims: The aim of this study was to assess the efficacy and safety of a novel, hydrophilic, bioenhanced curcumin (BEC) as add-on therapy in inducing clinical and endoscopic remission in mild to moderately active ulcerative colitis (UC). Design: Mild to moderately active UC patients (partial Mayo score 2 to 6 with endoscopic Mayo score >1) on standard dose of mesalamine were randomized to either 50 mg twice daily BEC or an identical placebo. Clinical response (≥2 reduction of partial Mayo score), clinical remission (partial Mayo score ≤1), and endoscopic remission (endoscopic Mayo score of ≤1) were evaluated at 6 weeks and 3 months. Responders were followed-up at 6 and 12 months for assessing maintenance of remission. Results: Sixty-nine patients were randomly assigned to BEC (n=34) and placebo (n=35). At 6 weeks, clinical and endoscopic remission occurred in 44.1% (15/34) and 35.3% (14/34) patients, respectively, compared with none in the placebo group (P<0.01). Clinical response was also significantly higher in the BEC group (18/34, 52.9%) compared with placebo (5/35, 14.3%) (P=0.001). The clinical remission, clinical response, and endoscopic remission rates at 3 months were 55.9% (19/34), 58.8% (20/34), 44% (16/34) and 5.7% (2/35), 28.6% (10/35), 5.7% (2/35) in BEC and placebo groups, respectively. At 6 and 12 months, 95% (18/19) and 84% (16/19) of the responders to BEC maintained clinical remission. None of the responders to placebo maintained clinical remission at 6 months. BEC appeared safe with no significant side effects. Conclusion: A low-dose BEC as add-on therapy was superior to placebo in inducing sustained clinical and endoscopic remission in patients with mild-to-moderately active UC on maximal dose of mesalamine (ClinicalTrials.gov: NCT02683733).
Hemoglobin A1c (HbA1c) is the gold standard for the measurement of long-range glycemic control in patients with diabetes mellitus type 2 (T2DM). In a rare subset of patients, this measurement may not be reliable. Inaccuracies of HbA1c in liver cirrhosis are rare, but documented. The objective of this study was to increase awareness about low HbA1c in liver cirrhosis and discuss alternative biomarkers that can be used to measure glycemic control. We present the case of a 61-year-old Caucasian female, with history of hepatitis C and uncontrolled T2DM, who was admitted for evaluation of compensated liver cirrhosis. She was found to have blood glucoses greater than 500 mg/ dL; however, her HbA1c was measured at 5.5%. Ultrasound of the abdomen showed liver cirrhosis, ascites, and splenomegaly. Blood work revealed acute kidney injury, anemia of chronic disease, normal albumin level, and low HbA1c. Fructosamine and glycated albumin were high, indicating a hyperglycemic status during the last 3 weeks. HbA1c can be falsely low in liver cirrhosis, and can give a false assumption about control of the diabetic disease process. In this case, other biomarkers can be used to monitor glycemic control; by far frequent finger stick monitoring is the best method.
INTRODUCTION: Nintedanib has emerged as an important treatment agent for Idiopathic Pulmonary Fibrosis (IPF). Gastrointestinal side effects, such as diarrhea and nausea, have been reported. However, Nintedanib-Induced Colitis, as described in the following cases, is a rare finding. CASE DESCRIPTION/METHODS: Case 1: 65 year-old man with a history of IPF on Nintedanib for three years presented with diarrhea. He reported two watery, non-bloody bowel movements daily with urgency, despite taking four tablets of loperamide daily. He had lower abdominal pain and an eighty-pound weight loss. A colonoscopy revealed mild edema, loss of vascular markings throughout the colon, and significant patches of submucosal hemorrhage/petechiae in the right colon. Biopsies revealed subepithelial deposition of amorphous eosinophilic material, prominently filling the subepithelial capillaries (Figure 1). Masson trichrome stain highlights dense blue staining, indicating collagen. The patient's symptoms resolved within a few days of discontinuing Nintedanib, and returned with rechallenge. Case 2: 76 year-old man with IPF on Nintedanib for three years presented with four loose, non-bloody bowel movements daily. He had bowel urgency, abdominal pain, and ten-pound weight loss despite loperamide use. Colonoscopy showed diffuse villous clubbing and erythema in the ileum. The entire colon revealed erythema and loss of vascular markings without ulcers (Figure 2). Histopathology revealed a paucicellular area of eosinophilic change in the lamina propria of the colon (Figure 3). There was no definite collagen deposition in this case. Nintedanib was discontinued and the patient's diarrhea resolved within two days; it returned with rechallenge. DISCUSSION: Nintedanib is a tyrosine kinase inhibitor, which is associated with diarrhea in about half of patients. Diarrhea is usually reported in the first three months of treatment and is generally adequately treated with anti-diarrheal medications. However, the specific entity of Nintedanib-induced colitis is a rare finding. There have only been two cases reported in the literature, neither of which described any particular pathologic findings. Our two cases demonstrate that symptoms resolve rapidly with drug withdrawal, recur rapidly upon rechallenge, and resolve again on withdrawal, suggesting a hypersensitivity reaction. Both cases demonstrate deposition of subepithelial eosinophilic material, which may offer a diagnostic clue to this drug induced diarrhea.
INTRODUCTION: Lymphocytic Gastritis (LG) is an uncommon gastritis that is typically associated with Helicobacter Pylori (HP) and Celiac disease. We present the case of a patient with persistent LG on repeat biopsies without either aforementioned association, which improved with steroids. CASE DESCRIPTION/METHODS: A 48-year old woman with a history of Raynaud’s and Undifferentiated Connective Tissue Disorder (UCTD) presented with abdominal pain, early satiety, and weight loss of forty-five pounds over three years. She was taking Advil twice weekly for headaches. CT Abdomen/Pelvis was unremarkable. Esophagogastroduodenoscopy (EGD) showed diffuse nodular mucosa with normal rugae (Figure 1); biopsies showed LG. There was no HP and duodenal biopsies were normal. She was started on Prednisone 40 mg daily for one week and tapered by 10 mg weekly, which significantly improved her symptoms. EGD three months later demonstrated a nodular stomach and biopsies showed mild to moderate LG, similar to prior exam. Steroids were not restarted as the patient was asymptomatic with weight increase of five pounds. In follow up two years later, she continued to be asymptomatic and had total weight increase of eighty pounds. Repeat EGD showed erythema and edema throughout gastric body with nodular-like appearance; this was improved from the first endoscopy. Biopsies at this time were normal without LG. DISCUSSION: LG is a rare subset of gastritis, seen in less than 1.5% of cases. Histologically, it is defined as a lymphocyte fraction of greater than twenty-five out of one hundred epithelial cells. Endoscopic appearance can include small, nodular erosions with enlarged rugae (an entity known as gastritis varioliformis), or it can present as giant fold gastritis. It has been described as a reaction to either HP infection or celiac sprue, which has been identified in up to 45% of cases. In this particular case, we describe a slightly different endoscopic appearance; HP and Celiac disease were both ruled out with negative biopsies. The literature has also identified a correlation of LG with Menetrier’s disease, autoimmune disorders, Crohn’s disease, viral (HIV) or parasitic infections. In this case, it is possible that she was predisposed to LG given her concurrent history of autoimmune disorders in the form of UCTD. NSAIDs may also have played a role, as they do in lymphocytic colitis. This case illustrates the successful treatment of LG with steroid therapy, which can lead to symptomatic and histologic remission.
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