Granulocyte and monocyte apheresis as an adjunctive therapy to induce and maintain clinical remission in ulcerative colitis: a systematic review and meta-analysis
BMJ open. 2021;11(5):e042374
OBJECTIVE The goal of treatment in ulcerative colitis (UC) is to induce and maintain remission. The addition of granulocyte and monocyte apheresis (GMA) to conventional therapy may be a promising therapeutic alternative. In this meta-analysis, we aimed to assess the efficacy and safety profile of GMA as an adjunctive therapy. DESIGN Systematic review and meta-analysis. METHODS We searched four databases (MEDLINE, Embase, Web of Science and Cochrane Central Register of Controlled Trials) for randomised or minimised controlled trials which discussed the impact of additional GMA therapy on clinical remission induction and clinical remission maintenance compared with conventional therapy alone. Primary outcomes were clinical remission induction and maintenance, secondary outcomes were adverse events (AEs) and steroid-sparing effect. ORs with 95% CIs were calculated. Trial Sequential Analyses were performed to adjusts for the risk of random errors in meta-analyses. RESULTS A total of 11 studies were eligible for meta-analysis. GMA was clearly demonstrated to induce and maintain clinical remission more effectively than conventional therapy alone (598 patients: OR: 1.93, 95% CI 1.28 to 2.91, p=0.002, I(2)=0.0% for induction; 71 patients: OR: 8.34, 95% CI 2.64 to 26.32, p<0.001, I(2)=0.0% for maintenance). There was no statistically significant difference in the number of AEs (OR: 0.27, 95% CI 0.05 to 1.50, p=0.135, I(2)=84.2%). CONCLUSION GMA appears to be more effective as an adjunctive treatment in inducing and maintaining remission in patients with UC than conventional therapy alone. PROSPERO REGISTRATION NUMBER CRD42019134050.
The role of refined nursing combined with targeted nursing in patients with digestive tract hemorrhages complicated by liver cirrhosis
American journal of translational research. 2021;13(5):5336-5342
OBJECTIVE To explore the effect of refined nursing combined with targeted nursing on patients with gastrointestinal bleeding complicated by liver cirrhosis. METHODS 128 patients with gastrointestinal bleeding and liver cirrhosis admitted to our hospital from April 2018 to April 2019 were recruited as the study cohort and were randomly divided into a control group and an experimental group with 64 patients in each group. The patients in the control group underwent conventional nursing, and the experimental group underwent refined nursing combined with targeted nursing. The two groups' clinical efficacy, complication rates, psychological states, prognoses, quality of life, and nursing satisfaction were statistically analyzed. RESULTS The clinical curative effect, prognosis complication rate, psychological state scores, quality of life scores, and nursing satisfaction in the experimental group were significantly better than they were in the control group (P<0.05). CONCLUSION Refined nursing combined with targeted nursing has a more significant clinical effect than the conventional nursing mode due to its strengths in improving patients' prognoses, psychological states, and quality of life, and reducing the incidence of complications, improving the patients' nursing satisfaction, and establishing good doctor-patient relationships.
Interventions for treating iron deficiency anaemia in inflammatory bowel disease
The Cochrane database of systematic reviews. 2021;1:Cd013529
BACKGROUND Inflammatory bowel disease affects approximately seven million people globally. Iron deficiency anaemia can occur as a common systemic manifestation, with a prevalence of up to 90%, which can significantly affect quality of life, both during periods of active disease or in remission. It is important that iron deficiency anaemia is treated effectively and not be assumed to be a normal finding of inflammatory bowel disease. The various routes of iron administration, doses and preparations present varying advantages and disadvantages, and a significant proportion of people experience adverse effects with current therapies. Currently, no consensus has been reached amongst physicians as to which treatment path is most beneficial. OBJECTIVES The primary objective was to evaluate the efficacy and safety of the interventions for the treatment of iron deficiency anaemia in people with inflammatory bowel disease. SEARCH METHODS We searched CENTRAL, MEDLINE, Embase, and two other databases on 21st November 2019. We also contacted experts in the field and searched references of trials for any additional trials. SELECTION CRITERIA Randomised controlled trials investigating the effectiveness and safety of iron administration interventions compared to other iron administration interventions or placebo in the treatment of iron deficiency anaemia in inflammatory bowel disease. We considered both adults and children, with studies reporting outcomes of clinical, endoscopic, histologic or surgical remission as defined by study authors. DATA COLLECTION AND ANALYSIS Two review authors independently conducted data extraction and 'Risk of bias' assessment of included studies. We expressed dichotomous and continuous outcomes as risk ratios and mean differences with 95% confidence intervals. We assessed the certainty of the evidence using the GRADE methodology. MAIN RESULTS We included 11 studies (1670 randomised participants) that met the inclusion criteria. The studies compared intravenous iron sucrose vs oral iron sulphate (2 studies); oral iron sulphate vs oral iron hydroxide polymaltose complex (1 study); oral iron fumarate vs intravenous iron sucrose (1 study); intravenous ferric carboxymaltose vs intravenous iron sucrose (1 study); erythropoietin injection + intravenous iron sucrose vs intravenous iron sucrose + injection placebo (1 study); oral ferric maltol vs oral placebo (1 study); oral ferric maltol vs intravenous ferric carboxymaltose (1 study); intravenous ferric carboxymaltose vs oral iron sulphate (1 study); intravenous iron isomaltoside vs oral iron sulphate (1 study); erythropoietin injection vs oral placebo (1 study). All studies compared participants with CD and UC together, as well as considering a range of disease activity states. The primary outcome of number of responders, when defined, was stated to be an increase in haemoglobin of 20 g/L in all but two studies in which an increase in 10g/L was used. In one study comparing intravenous ferric carboxymaltose and intravenous iron sucrose, moderate-certainty evidence was found that intravenous ferric carboxymaltose was probably superior to intravenous iron sucrose, although there were responders in both groups (150/244 versus 118/239, RR 1.25, 95% CI 1.06 to 1.46, number needed to treat for an additional beneficial outcome (NNTB) = 9). In one study comparing oral ferric maltol to placebo, there was low-certainty evidence of superiority of the iron (36/64 versus 0/64, RR 73.00, 95% CI 4.58 to 1164.36). There were no other direct comparisons that found any difference in the primary outcomes, although certainty was low and very low for all outcomes, due to imprecision from sparse data and risk of bias varying between moderate and high risk. The reporting of secondary outcomes was inconsistent. The most common was the occurrence of serious adverse events or those requiring withdrawal of therapy. In no comparisons was there a difference seen between any of the intervention agents being studied, although the certainty was very low for all comparisons made, due to risk of bias and significant imprecision due to the low numbers of events. Time to remission, histological and biochemical outcomes were sparsely reported in the studies. None of the other secondary outcomes were reported in any of the studies. An analysis of all intravenous iron preparations to all oral iron preparations showed that intravenous administration may lead to more responders (368/554 versus 205/373, RR 1.17, 95% CI 1.05 to 1.31, NNTB = 11, low-certainty due to risk of bias and inconsistency). Withdrawals due to adverse events may be greater in oral iron preparations vs intravenous (15/554 versus 31/373, RR 0.39, 95% CI 0.20 to 0.74, low-certainty due to risk of bias, inconsistency and imprecision). AUTHORS' CONCLUSIONS Intravenous ferric carboxymaltose probably leads to more people having resolution of IDA (iron deficiency anaemia) than intravenous iron sucrose. Oral ferric maltol may lead to more people having resolution of IDA than placebo. We are unable to draw conclusions on which of the other treatments is most effective in IDA with IBD (inflammatory bowel disease) due to low numbers of studies in each comparison area and clinical heterogeneity within the studies. Therefore, there are no other conclusions regarding the treatments that can be made and certainty of all findings are low or very low. Overall, intravenous iron delivery probably leads to greater response in patients compared with oral iron, with a NNTB (number needed to treat) of 11. Whilst no serious adverse events were specifically elicited with any of the treatments studied, the numbers of reported events were low and the certainty of these findings very low for all comparisons, so no conclusions can be drawn. There may be more withdrawals due to such events when oral is compared with intravenous iron delivery. Other outcomes were poorly reported and once again no conclusions can be made as to the impact of IDA on any of these outcomes. Given the widespread use of many of these treatments in practice and the only guideline that exists recommending the use of intravenous iron in favour of oral iron, research to investigate this key issue is clearly needed. Considering the current ongoing trials identified in this review, these are more focussed on the impact in specific patient groups (young people) or on other symptoms (such as fatigue). Therefore, there is a need for studies to be performed to fill this evidence gap.
Is There a Role for Tranexamic Acid in Upper GI Bleeding? A Systematic Review and Meta-Analysis
Surgery research and practice. 2021;2021:8876991
INTRODUCTION Upper gastrointestinal (GI) bleeding is associated with increased morbidity and mortality. Tranexamic acid (TXA) is an antifibrinolytic agent which is licensed in the management of haemorrhage associated with trauma. It has been suggested that tranexamic acid may be able to play a role in upper GI bleeding. However, there is currently no recommendation to support this. AIM: The aim of this study was to synthesise available evidence of the effect of TXA on upper GI bleeding. METHODS AND MATERIALS A systematic review was conducted. PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for relevant studies. A random effects meta-analysis was performed to determine the risk ratio of primary and secondary outcomes pertaining to the use of TXA in upper GI bleeding. RESULTS A total of 8 studies were included in this systematic review. The total number of patients in all studies was 12994 including 4550 females (35%) and 8444 males (65%). The mean age of participants in 6 of the studies was 59.3; however the mean age for either intervention or placebo group was not reported in two of the studies. All studies reported on the effect of TXA on mortality, and the risk ratio was 0.95; however, with the 95% CI ranging from 0.80 to 1.13, this was not statistically significant. 6 of the studies reported on rebleeding rate, the risk ratio was 0.64, and with a 95% CI ranging from 0.47 to 0.86, this was statistically significant. 3 of the studies reported on the risk of adverse thromboembolic events, and the risk ratio was 0.93; however, the 95% CI extended from 0.62 to 1.39 and so was not statistically significant. 7 of the studies reported on the need for surgery, and the risk ratio was 0.59 and was statistically significant with a 95% CI ranging from 0.38 to 0.94. CONCLUSION In conclusion, the use of TXA in upper GI bleeding appears to have a beneficial effect in terms of decreasing the risk of re-bleeding and decreasing the need for surgery. However, we could not find a statistically significant effect on need for blood transfusions, risk of thromboembolic events, or effect on mortality. Future randomised controlled trials may elucidate these outcomes.
Patients with upper gastrointestinal (GI) bleeding (8 studies, n= 12,994).
Meta-analysis to synthesise available evidence of the effect of tranexamic acid (TXA) on upper GI bleeding.
All studies reported on the effect of TXA on mortality, and the risk ratio was 0.95; however, this was not statistically significant. 6 of the studies reported on rebleeding rate, the risk ratio was 0.64, and this was statistically significant. 3 of the studies reported on the risk of adverse thromboembolic events, and the risk ratio was 0.93; however, was not statistically significant. 7 of the studies reported on the need for surgery, and the risk ratio was 0.59 and was statistically significant.
Oral Proton Pump Inhibitors May Be as Effective as Intravenous in Peptic Ulcer Bleeding: A Systematic Review and Meta-analysis
Clinical and translational gastroenterology. 2021;12(4):e00341
INTRODUCTION Current guidelines recommend intravenous (IV) proton pump inhibitor (PPI) therapy in peptic ulcer bleeding (PUB). We aimed to compare the efficacy of oral and IV administration of PPIs in PUB. METHODS We performed a systematic search in 4 databases for randomized controlled trials, which compared the outcomes of oral PPI therapy with IV PPI therapy for PUB. The primary outcomes were 30-day recurrent bleeding and 30-day mortality. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for dichotomous outcomes, while weighted mean differences (WMDs) with CI were calculated for continuous outcomes in meta-analysis. The protocol was registered a priori onto PROSPERO (CRD42020155852). RESULTS A total of 14 randomized controlled trials reported 1,951 peptic ulcer patients, 977 and 974 of which were in the control and intervention groups, respectively. There were no statistically significant differences between oral and IV administration regarding 30-day rebleeding rate (OR = 0.96, CI: 0.65-1.44); 30-day mortality (OR = 0.70, CI: 0.35-1.40); length of hospital stay (WMD = -0.25, CI: -0.93 to -0.42); transfusion requirements (WMD = -0.09, CI: -0.07 to 0.24); need for surgery (OR = 0.91, CI: 0.40-2.07); further endoscopic therapy (OR = 1.04, CI: 0.56-1.93); and need for re-endoscopy (OR = 0.81, CI: 0.52-1.28). Heterogeneity was negligible in all analysis, except for the analysis on the length of hospitalization (I2 = 82.3%, P = 0.001). DISCUSSION Recent evidence suggests that the oral administration of PPI is not inferior to the IV PPI treatment in PUB after endoscopic management, but further studies are warranted.
Effectiveness of hemostatic powders in lower gastrointestinal bleeding: a systematic review and meta-analysis
Endoscopy international open. 2021;9(8):E1283-e1290
Background and study aims There is limited evidence on the effectiveness of hemostatic powders in the management of lower gastrointestinal bleeding (LGIB). We aimed to provide a pooled estimate of their effectiveness and safety based on the current literature. Patients and methods Literature review was based on computerized bibliographic search of the main databases through to December 2020. Immediate hemostasis, rebleeding rate, adverse events, and mortality were the outcomes of the analysis. Pooled effects were calculated using a random-effects model. Results A total of 9 studies with 194 patients were included in the meta-analysis. Immediate hemostasis was achieved in 95 % of patients (95 % confidence interval [CI] 91.6 %-98.5 %), with no difference based on treatment strategy or bleeding etiology. Pooled 7- and 30-day rebleeding rates were 10.9 % (95 %CI 4.2 %-17.6 %) and 14.3 % (95 %CI 7.3 %-21.2 %), respectively. Need for embolization and surgery were 1.7 % (95 %CI 0 %-3.5 %) and 2.4 % (95 %CI 0.3 %-4.6 %), respectively. Overall, two patients (1.9 %, 95 %CI 0 %-3.8 %) experienced mild abdominal pain after powder application, and three bleeding-related deaths (2.3 %, 95 %CI 0.2 %-4.3 %) were registered in the included studies. Conclusion Novel hemostatic powders represent a user-friendly and effective tool in the management of lower gastrointestinal bleeding.
High pooled performance of convolutional neural networks in computer-aided diagnosis of GI ulcers and/or hemorrhage on wireless capsule endoscopy images: a systematic review and meta-analysis
Gastrointest Endosc. 2020
BACKGROUND AND AIMS Diagnosis of gastrointestinal (GI) ulcers and/or hemorrhage by wireless capsule endoscopy (WCE) is limited by the physician-dependent, tedious, time-consuming process of image and/ or video classification. Computer-aided diagnosis (CAD) by convolutional neural networks (CNN) based machine learning may help reduce this burden. Our aim was to conduct a meta-analysis and appraise the reported data. METHODS Multiple databases were searched (from inception to November 2019) and studies that reported on the performance of CNN in the diagnosis of GI ulcerations and/ or hemorrhage on WCE were selected. Random effects model was used to calculate the pooled rates. In cases where multiple 2X2 contingency tables were provided for different thresholds, we assumed the data tables as independent from each other. Heterogeneity was assessed by I(2)% and 95% prediction intervals. RESULTS Nine studies were included in our final analysis that evaluated the performance of CNN based CAD of GI ulcers and/ or hemorrhage by WCE. The pooled accuracy was 95.4% (95% CI, 94.3-96.3), sensitivity was 95.5% (95% CI, 94-96.5), specificity was 95.8% (95% CI, 94.7-96.6), positive predictive value was 95.8% (95% CI, 90.5-98.2) and negative predictive value was 96.8% (95% CI, 94.9-98.1). I(2)% heterogeneity was negligible except for the pooled positive predictive value. CONCLUSIONS Based on our meta-analysis, CNN based CAD of GI ulcerations and/ or hemorrhage on WCE achieves high-level performance. The quality of evidence is robust and therefore CNN based CAD has the potential to become the first-choice of machine learning to optimize WCE image/video reading.
Comparison in the diagnostic yield between "Pillcam SB3" capsule endoscopy and "OMOM Smart Capsule 2" in small bowel bleeding. A randomized head-to-head study
Digestive diseases (Basel, Switzerland). 2020
Introduction Capsule endoscopy is the first-line tool for diagnosis of small bowel bleeding. There are some studies that have compared different types of capsule endoscopy. OMOM capsule endoscopy is one of the newest in the market, and has not been compared to other types of capsule endoscopy. The objective of this study was to compare the diagnostic yield of the Pillcam SB3 and OMOM capsule endoscopy in small bowel bleeding. Material and methods This is a prospective, comparative, randomized and blinded study. Patients with suspected small bowel bleeding were included. All the patients were given both types of capsules endoscopy in random order. Diagnostic yield and functionality between the two types of capsule endoscopy were analyzed. Results We included 44 patients, 54.5% female with a median of 63.5 years old. Battery time was significantly longer with SB3 (816.5 vs. 700.5 minutes, p<0.001) and the download time was shorter with the OMOM (33 vs. 132 minutes, p<0.001). Both capsule endoscopies presented one failure. The cause of the bleeding was identified in 39 SB3 (88.6%) and in 34 OMOM CE (77.3%) (p=0.256). P2 lesions were observed in 32 SB3 (72.7%) and in 29 OMOM (65.9%) (p=0.784). The agreement between both capsule endoscopies for P2 lesions was moderate (κ=0.628). Conclusions Pillcam SB3 and OMOM devices are safe procedures and have a similar diagnostic yield. Significant differences were observed in the battery life and download time with both capsule endoscopies.
Efficacy and safety of tranexamic acid in acute upper gastrointestinal bleeding: meta-analysis of randomised controlled trials
Scandinavian journal of gastroenterology. 2020;:1-8
BACKGROUND Studies evaluating the role of tranexamic acid in acute upper GI bleeding (UGIB) have reported conflicting results. In this systematic review, we have evaluated the efficacy and safety of tranexamic acid in UGIB. METHODS We searched several databases from inception to June 6, 2020 to identify randomised controlled trials (RCTs) that compared tranexamic acid and placebo in UGIB. Our outcomes of interest were mortality, rebleeding, all thromboembolic events, venous thromboembolic events, need for transfusion, endoscopic intervention and surgery. Pooled risk ratios (RR) with 95% confidence intervals (CI) were calculated using fixed effect model. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework to assess the certainty of evidence. RESULTS We included 12 RCTs comprising 14,100 patients. We found no significant difference in mortality, pooled RR (95% CI) 0.87 (0.74-1.01), rebleeding, pooled RR (95% CI) 0.90 (0.79-1.02), need for surgery, pooled RR (95% CI) 0.86 (0.73-1.02), need for transfusion, pooled RR (95% CI) 1.00 (0.99-1.01) or thromboembolic events, RR (95% CI) 1.16 (0.87-1.56) between treatments. We found an increased risk of venous thromboembolic events with tranexamic acid, pooled RR (95% CI) 1.94 (1.23-3.05). Certainty of evidence based on the GRADE framework for the different outcomes ranged from low to very low. CONCLUSIONS Tranexamic acid does not improve outcomes in UGIB and may increase the risk of venous thromboembolic events.
Patients with acute upper gastrointestinal bleeding bleeding (12 studies, n= 14,100).
Tranexamic acid (n= 7101).
Placebo (n= 6999).
No significant difference in mortality, rebleeding, need for surgery, need for transfusion, or thromboembolic events, between treatments was found. However, there was an increased risk of venous thromboembolic events with tranexamic acid.
Efficacy and Safety of IV albumin for non-spontaneous bacterial peritonitis infection among patients with cirrhosis: A systematic review and meta-analysis
Dig Liver Dis. 2020
Efficacy and Safety of intravenous albumin for non-spontaneous bacterial peritonitis infection among patients with cirrhosis: A systematic review and meta-analysis of randomized controlled trials INTRODUCTION Bacterial infection is a common cause of acute-on-chronic liver failure (ACLF) and death among cirrhosis. The benefit of intravenous (IV) albumin among cirrhosis with non-SBP infection remains unclear as individual studies are underpowered to detect the survival benefit of IV albumin. AIM: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of intravenous albumin for non-SBP infection among cirrhosis patients. METHODS We performed a systematic search of electronic databases (Pubmed, MEDLINE and Clinicalkey) up to 1(st) December 2019. Studies evaluating IV albumin for non-SBP infection were selected. Using random effect model, the pooled odds ratio (OR), 95% confidence interval (95%CI) and heterogeneity were assessed. RESULTS A total of 3 RCTs (406 subjects) fulfilling the inclusion criteria among 218 citations were identified. There was no significant heterogeneity across included studies. In this meta-analysis, we found that the pooled risk of renal impairment (RI) (OR=0.58, 95%CI: 0.28-1.23, I(2)=0%), mortality at 30 days (OR=1.61, 95%CI: 0.87-3.00, I(2)=0%) as well as mortality at 90 days (OR=1.30, 95%CI: 0.81-2.07, I(2)=0%) were similar between albumin and control group. Pooled event of pulmonary edema occurred more commonly in albumin group (OR 5.17, 95%CI 1.62-16.47, I(2)=0%). More subjects achieved resolution of ACLF in IV albumin group as compared to control group (OR=0.11, 95%CI: 0.02-0.69, p=0.02). CONCLUSION Albumin did not reduce the risk of RI and mortality, yet increases the risk of pulmonary edema. Albumin may promote recovery of ACLF, however, more data is required to validate this benefit.