What does this research mean for the field?

Meta-analysis of existing trials establishes the excess risk of gastrointestinal complications from NSAID and aspirin therapy, demonstrating that adequately powered randomized controlled trials to test prophylactic measures are statistically feasible with calculated sample sizes. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To estimate the excess risk of rare gastrointestinal complications associated with aspirin and non-aspirin NSAIDs in order to calculate sample size requirements for future prophylactic trials.

April 1, 1988Alimentary Pharmacology & Therapeutics

Meta‐analysis of randomized controlled trials as a method of estimating rare complications of non‐steroidal anti‐inflammatory drug therapy

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Why the study?

Do NSAIDs increase the risk of gastrointestinal complications compared to non-anti-inflammatory controls?

Population

Patients in 44 aspirin trials and 123 non-aspirin non-steroidal anti-inflammatory drug trials. Inclusion…

Comparison

Aspirin or non-aspirin non-steroidal… vs Non-anti-inflammatory drug control group

Design

Meta-analysis

Follow-up

mean 357 days for aspirin trials, 67 days for NA-NSAID…

Authors

TCT. C. ChalmersNational Institutes of Health Clinical Center JBJayne BerrierMount Sinai Hospital PHPeg HewittTufts University

Discussion

Member takes

Implication

Provides RCT-derived excess GI risk estimates to guide NSAID prescribing caution; extends evidence for designing future prophylaxis trials.

Key Points

To estimate the excess risk of rare gastrointestinal complications associated with aspirin and non-aspirin NSAIDs in order to calculate sample size requirements for future prophylactic trials.
Screened 952 randomized controlled trials from MEDLINE, blinding source and results for review, to include studies with non-drug controls, at least 4 days of treatment, and documented gastrointestinal side effects.
Analyzed 44 aspirin trials (mean duration 357 days) and 123 non-aspirin NSAID trials (mean duration 67 days), calculating unweighted rate differences and random-effects pooled risk differences using the DerSimonian and Laird method.
In aspirin trials, unweighted rate differences (±1 SEM) between treatment and control were 0.006 ± 0.003 for ulcer, 0.006 ± 0.002 for gross haemorrhage, and 0.03 ± 0.01 for unspecified gastric symptoms.
In non-aspirin NSAID trials, unweighted rate differences were 0.0005 ± 0.0003 for ulcer, 0.007 ± 0.004 for gross haemorrhage, and 0.02 ± 0.005 for unspecified gastric symptoms; DerSimonian-Laird pooling showed statistical significance only for aspirin haemorrhage and NSAID gastric symptoms.
Prophylactic trials to detect a 50% reduction in ulcer rates require 950 patients per group for 2- to 6-month non-aspirin NSAID therapy and 3,346 patients per group for aspirin therapy lasting over 6 months.

Structured PICO

Do NSAIDs increase the risk of gastrointestinal complications compared to non-anti-inflammatory controls?

Population

Patients in 44 aspirin trials and 123 non-aspirin non-steroidal anti-inflammatory drug (NA-NSAID) trials. Inclusion criteria: non-anti-inflammatory drug control group, at least 4 days of therapy, at least 3 days without anti-inflammatory drugs before randomization, no complicating background drugs, mention of side-effects, and clear differentiation of gastrointestinal complications.

Intervention

Aspirin or non-aspirin non-steroidal anti-inflammatory drugs (NA-NSAIDs) for at least 4 days

Comparator

Non-anti-inflammatory drug control group

Outcome

Gastrointestinal complications including ulcer, gross haemorrhage, and unspecified gastric symptomssafety

Meta-analysis of RCTs provides estimates of excess risk for gastrointestinal complications with NSAID therapy, useful for designing future prophylactic trials.

Cite This Study

Chalmers et al. (1988) studied this question.

synapsesocial.com/papers/6a155fb679ff98d0de4e87dd https://doi.org/10.1111/j.1365-2036.1988.tb00761.x

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Implication

Provides RCT-derived excess GI risk estimates to guide NSAID prescribing caution; extends evidence for designing future prophylaxis trials.

Meta‐analysis of randomized controlled trials as a method of estimating rare complications of non‐steroidal anti‐inflammatory drug therapy

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Meta‐analysis of randomized controlled trials as a method of estimating rare complications of non‐steroidal anti‐inflammatory drug therapy

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Also Consider

Also Consider