Mortality With Upper Gastrointestinal Bleeding and Perforation: Effects of Time and NSAID Use

Sebastian Straube; Martin R Tramèr; R. Andrew Moore; Sheena Derry; Henry J. McQuay

Disclosures

BMC Gastroenterol 

In This Article

Methods

Guidelines for quality of reporting of meta-analyses were followed where appropriate.[12] We took data from a previous systematic review[1] of studies published up to and including 1996. To identify more recent studies (published between 1997 and October 2008), we conducted a MEDLINE (PubMed) search for full publications; the date of the last search was 6 November 2008. The search was limited to 'humans' and the search strategy involved a combination of the search terms "non-steroidal anti-inflammatory", "aspirin", "upper gastrointestinal" (or "upper gastro-intestinal" or "upper GI"), "ulcer", "bleeding", "haemorrhage", "perforation", "death", and "mortality". We also contacted experts in the field for further studies. Only a small proportion of observational studies are identified through electronic searching.[13,14] Reference lists of retrieved studies, reviews, and articles that commented on formulary policy were also searched carefully for further reports. No formal quality assessments were made.

We identified reports of any kind of clinical study published in any language that contained information about mortality with upper gastrointestinal bleeding or perforation. We sought data on the number of patients experiencing upper gastrointestinal bleeds or perforations (cases), and the number of these cases who died (deaths). We sought data on the total number of cases and deaths, and those in patients using NSAIDs. NSAIDs included aspirin when it was used as an analgesic, but not low dose aspirin used for prophylaxis of myocardial infarction or stroke. Coxibs were included in the broader definition of NSAIDs.

We calculated mortality rates as the number of deaths divided by the number of cases with 95% confidence intervals (CI). This was done for all patients independent of NSAID exposure and for NSAID users separately; we were unable to identify non-NSAID users separately from all patients, and so all patient data are "contaminated" by the inclusion of patients who were taking NSAID or aspirin. Similarly, we calculated mortality rates for all times, and for the time periods 'prior to 1997' and '1997-2008' separately. Where papers reported separate datasets for different diagnoses (gastric, duodenal, or peptic ulcer;[4] for instance), we used these separate datasets in any analysis. Definitions of mortality were taken as reported in the original reports. Differences between proportions were assessed using both the t-test and Fisher's exact test, using an interactive Internet statistical package https://www.quantitativeskills.com/sisa/index.htm webcite. Two sided tests were used, with statistical significance set at p < 0.05.

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