Randomised control trial

Barer D, Ogilvie A, Henry D, et al
Cimetidine and Tranexamic Acid in the Treatment of Acute Upper- Gastrointestial-Tract Bleeding
The New England Journal of Medicine
1983; 308: 1571-1575

Submitted by:Anna Morgan - ST6 Emergency Medicine
Institution:Homerton Hospital
Date submitted:21st May 2011

Before CA, i rated this paper: 7/10

1 Objectives and hypotheses

1.1 Are the objectives of the study clearly stated?

Yes; to investigate the value of cimetidine and tranexamic acid in patients having an upper gastrointestinal bleed.

2 Design

2.1 Is the study design suitable for the objectives

Yes is a randomised control trial.

2.2 Who / what was studied?

775 patients who presented with a primary complaint of hematemesis or melena. Patients were excluded if bleeding was so severe that immediate operation was necessary, if other serious medical conditions primarily affected management or if bleeding was not considered serious. Patients were randomised to either receive cimetidine, tranexaic acid or a placebo.

2.3 Was this the right sample to answer the objectives?

Yes

2.4 Is the study large enough to achieve its objectives? Have sample size estimates been performed?

Sample size estimates were calculated. However, the rate of rebleeding and operations in the population studied were smaller than that estimated by the power calculation.

2.5 Were all subjects accounted for?

Yes - but 13% were withdrawn from the trial.

2.6 Were all appropriate outcomes considered?

Yes, outcomes considered were death, operation rates, transfusion rates and rates of rebleeding.

2.7 Has ethical approval been obtained if appropriate?

Not commented on.

2.8 Were the patients randomised between treatments?

Yes

2.9 How was randomisation carried out?

Randomised in blocks of six with sealed copies of randomisation schedule being held by hospital pharmacy.

2.10 Are the outcomes clinically relevant?

Yes

3 Measurement and observation

3.1 Is it clear what was measured, how it was measured and what the outcomes were?

Yes

3.2 Are the measurements valid?

Yes

3.3 Are the measurements reliable?

Yes

3.4 Are the measurements reproducible?

Yes

3.5 Were the patients and the investigators blinded?

Yes, however placebo tablets of tranexamic acid and cimetidine had different appearances.

4 Presentation of results

4.1 Are the basic data adequately described?

Yes

4.2 Were groups comparable at baseline?

Yes

4.3 Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?

Yes

4.4 Are the results internally consistent, i.e. do the numbers add up properly?

Yes

4.5 Were side effects reported?

Yes

5 Analysis

5.1 Are the data suitable for analysis?

Yes

5.2 Are the methods appropriate to the data?

Yes

5.3 Are any statistics correctly performed and interpreted?

Yes

6 Discussion

6.1 Are the results discussed in relation to existing knowledge on the subject and study objectives?

Yes

6.2 Is the discussion biased?

7 Interpretation

7.1 Are the authors' conclusions justified by the data?

Yes

7.2 What level of evidence has this paper presented? (using CEBM levels)

7.3 Does this paper help me answer my problem?

Suggests that tranexamic acid reduced mortality rates in a population of patients having upper gastrointestinal bleeding at time of study. Lacks external validity as other treatments for patients with an upper gastrointestinal bleed have changed since the time that the study was undertaken.

After CA, i rated this paper: 8/10

8 Implementation

8.1 Can any necessary change be implemented in practice?

Yes

8.2 What aids to implementation exist?

8.3 What barriers to implementation exist?