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      Corticosteroids and risk of gastrointestinal bleeding: a systematic review and meta-analysis

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      Author(s): 1 , 2 , 3 , 4 , 5
      Publication date (Electronic):
      Journal: BMJ Open
      Publisher: BMJ Publishing Group
      Keywords: Clinical Pharmacology, Epidemiology

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          Abstract

          Objective

          To assess whether corticosteroids are associated with increased risk of gastrointestinal bleeding or perforation.

          Design

          Systematic review and meta-analysis of randomised, double-blind, controlled trials comparing a corticosteroid to placebo for any medical condition or in healthy participants. Studies with steroids given either locally, as a single dose, or in crossover studies were excluded.

          Data sources

          Literature search using MEDLINE, EMBASE and Cochrane Database of Systematic Reviews between 1983 and 22 May 2013.

          Outcome measure

          Outcome measures were the occurrence of gastrointestinal bleeding or perforation. Predefined subgroup analyses were carried out for disease severity, use of non-steroidal anti-inflammatory drugs (NSAIDs) or gastroprotective drugs, and history of peptic ulcer.

          Results

          159 studies (N=33 253) were included. In total, 804 (2.4%) patients had a gastrointestinal bleeding or perforation (2.9% and 2.0% for corticosteroids and placebo). Corticosteroids increased the risk of gastrointestinal bleeding or perforation by 40% (OR 1.43, 95% CI 1.22 to 1.66). The risk was increased for hospitalised patients (OR 1.42, 95% CI 1.22 to 1.66). For patients in ambulatory care, the increased risk was not statistically significant (OR 1.63, 95% CI 0.42 to 6.34). Only 11 gastrointestinal bleeds or perforations occurred among 8651 patients in ambulatory care (0.13%). Increased risk was still present in subgroup analyses (studies with NSAID use excluded; OR 1.44, 95% CI 1.20 to 1.71, peptic ulcer as an exclusion criterion excluded; OR 1.47, 95% CI 1.21 to 1.78, and use of gastroprotective drugs excluded; OR 1.42, 95% CI 1.21 to 1.67).

          Conclusions

          Corticosteroid use was associated with increased risk of gastrointestinal bleeding and perforation. The increased risk was statistically significant for hospitalised patients only. For patients in ambulatory care, the total occurrence of bleeding or perforation was very low, and the increased risk was not statistically significant.

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          Most cited references19

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          The hazards of scoring the quality of clinical trials for meta-analysis.

          Peter Jüni (1999)
          Although it is widely recommended that clinical trials undergo some type of quality review, the number and variety of quality assessment scales that exist make it unclear how to achieve the best assessment. To determine whether the type of quality assessment scale used affects the conclusions of meta-analytic studies. Meta-analysis of 17 trials comparing low-molecular-weight heparin (LMWH) with standard heparin for prevention of postoperative thrombosis using 25 different scales to identify high-quality trials. The association between treatment effect and summary scores and the association with 3 key domains (concealment of treatment allocation, blinding of outcome assessment, and handling of withdrawals) were examined in regression models. Pooled relative risks of deep vein thrombosis with LMWH vs standard heparin in high-quality vs low-quality trials as determined by 25 quality scales. Pooled relative risks from high-quality trials ranged from 0.63 (95% confidence interval [CI], 0.44-0.90) to 0.90 (95% CI, 0.67-1.21) vs 0.52 (95% CI, 0.24-1.09) to 1.13 (95% CI, 0.70-1.82) for low-quality trials. For 6 scales, relative risks of high-quality trials were close to unity, indicating that LMWH was not significantly superior to standard heparin, whereas low-quality trials showed better protection with LMWH (P<.05). Seven scales showed the opposite: high quality trials showed an effect whereas low quality trials did not. For the remaining 12 scales, effect estimates were similar in the 2 quality strata. In regression analysis, summary quality scores were not significantly associated with treatment effects. There was no significant association of treatment effects with allocation concealment and handling of withdrawals. Open outcome assessment, however, influenced effect size with the effect of LMWH, on average, being exaggerated by 35% (95% CI, 1%-57%; P= .046). Our data indicate that the use of summary scores to identify trials of high quality is problematic. Relevant methodological aspects should be assessed individually and their influence on effect sizes explored.
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            Risk factors for gastrointestinal bleeding in critically ill patients. Canadian Critical Care Trials Group.

            H Fuller, Bruce Cook, D Leasa … (1994)
            The efficacy of prophylaxis against stress ulcers in preventing gastrointestinal bleeding in critically ill patients has led to its widespread use. The side effects and cost of prophylaxis, however, necessitate targeting preventive therapy to those patients most likely to benefit. We conducted a prospective multicenter cohort study in which we evaluated potential risk factors for stress ulceration in patients admitted to intensive care units and documented the occurrence of clinically important gastrointestinal bleeding (defined as overt bleeding in association with hemodynamic compromise or the need for blood transfusion). Of 2252 patients, 33 (1.5 percent; 95 percent confidence interval, 1.0 to 2.1 percent) had clinically important bleeding. Two strong independent risk factors for bleeding were identified: respiratory failure (odds ratio, 15.6) and coagulopathy (odds ratio, 4.3). Of 847 patients who had one or both of these risk factors, 31 (3.7 percent; 95 percent confidence interval, 2.5 to 5.2 percent) had clinically important bleeding. Of 1405 patients without these risk factors, 2 (0.1 percent; 95 percent confidence interval, 0.02 to 0.5 percent) had clinically important bleeding. The mortality rate was 48.5 percent in the group with bleeding and 9.1 percent in the group without bleeding (P < 0.001). Few critically ill patients have clinically important gastrointestinal bleeding, and therefore prophylaxis against stress ulcers can be safely withheld from critically ill patients unless they have coagulopathy or require mechanical ventilation.
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              Long-term use of acid suppression started inappropriately during hospitalization.

              Steven D. Zink, Zachary Barnes, M Pohlman … (2005)
              Practitioners routinely misuse acid suppression medications on general medical floors and inappropriately continue the drug at discharge. To: (i) retrospectively study the appropriateness of acid suppression use on the general medical floors; (ii) characterize the patient population discharged on unnecessary acid suppression and (iii) evaluate whether patients discharged on unnecessary acid suppression continue the medicine long term. Retrospective chart review of general medical patients admitted to an in-patient teaching service over 6 consecutive months. About 60% of patients lacked an indication for initiation of acid suppression and 34% of these patients were discharged on the medicine. The only independent predictor of continuation of acid suppression at discharge was longer length of stay. Multivariate analysis did not identify a characteristic distinguishing those patients discharged inappropriately on acid suppression. At 3 and 6 months of follow-up, 80% and 50% of patients, respectively, remained on acid suppression therapy without an appropriate indication. Our data verifies that practitioners routinely start general medical in-patients on acid suppression without an appropriate indication. Many of these prescriptions are continued at discharge for no apparent reason, leading to their long-term misuse.
              Article 0 comments Cited 49 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2014
                Publication date (Electronic): 15 May 2014
                Volume: 4
                Issue: 5
                Electronic Location Identifier: e004587
                Affiliations
                [1 ]Center for Psychopharmacology , Diakonhjemmet Hospital , Oslo, Norway
                [2 ]Department of Pharmacology, Oslo University Hospital , Oslo, Norway
                [3 ]Department of Pharmacology, Regional Medicines Information & Pharmacovigilance Centre (RELIS), Oslo University Hospital , Oslo, Norway
                [4 ]Norwegian Knowledge Centre for the Health Services , Oslo, Norway
                [5 ]Department of Pharmacology, University of Oslo , Oslo, Norway
                Author notes
                [Correspondence to ] Sigrid Narum; sigrid.narum@ 123456diakonsyk.no
                Article
                Publisher ID: bmjopen-2013-004587
                DOI: 10.1136/bmjopen-2013-004587
                PMC ID: 4025450
                PubMed ID: 24833682
                SO-VID: 8b471c0c-de30-4f56-b1da-11cf0033d418
                Copyright © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions
                License:

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

                History
                Date received : 30 November 2013
                Date revision received : 23 April 2014
                Date accepted : 25 April 2014
                Categories
                Subject: Gastroenterology and Hepatology
                Subject: Research
                Subject: 1506
                Subject: 1695
                Subject: 1692
                Subject: 1694
                Subject: 1707

                ScienceOpen disciplines: Medicine
                Keywords: clinical pharmacology,epidemiology
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: clinical pharmacology, epidemiology

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