Randomised control trial
Imazio, Massimo et al.Colchicine in Addition to Conventional Therapy for Acute Pericarditis
Circulation
2005;112:2012-2016
- Submitted by:Alex Eppert - EM Resident
- Institution:GRMERC
- Date submitted:5th April 2006
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes, to verigy the safety and efficacy of colchicine as an adjunct to conventional therapy for treatment of the first episode of acute pericarditis and for prevention of recurrences.
2
Design
2.1
Is the study design suitable for the objectives
Yes, prospective randomized open-label design
2.2
Who / what was studied?
Individuals age 18 years old or greater with a first episode of acute pericarditis.
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?
Yes, pg 2013
2.5
Were all subjects accounted for?
Yes, follow-up data were available on all patients for a mean follow-up of 24 months
2.6
Were all appropriate outcomes considered?
Yes
2.7
Has ethical approval been obtained if appropriate?
Yes
2.8
Were the patients randomised between treatments?
Yes
2.9
How was randomisation carried out?
Randomization was based on permuted blocks, with a block size of four
2.10
Are the outcomes clinically relevant?
Yes. Recurrence rate and symptoms at 72 hours are relevant clinically
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes. Recurrence rate and symptom persistence at 72 hours were measured by clinical and echocardiographic follow-up
3.2
Are the measurements valid?
Yes
3.3
Are the measurements reliable?
Yes, validation of clinical events was by ad-hoc committe of expert cardiologists
3.4
Are the measurements reproducible?
Yes
3.5
Were the patients and the investigators blinded?
No, the investigators were blinded but the patients were not.
4
Presentation of results
4.1
Are the basic data adequately described?
Yes
4.2
Were groups comparable at baseline?
Yes, Table 1
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. The chief limiting side effect of colchicine is GI intolerance, which is why investigators used weight-based dosing. Still, 5 of 60 patients in the colchicine arm discontinued the drug because of GI symptoms (diarrhea).
5
Analysis
5.1
Are the data suitable for analysis?
Yes, five patients needed to be treated with colchicine to prevent one additional recurrence
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?
No
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)
IB
7.3
Does this paper help me answer my problem?
Yes
8
Implementation
8.1
Can any necessary change be implemented in practice?
Yes, it would be easy to add colchicine to the standard treatment regimen of NSAIDS.
8.2
What aids to implementation exist?
Colchicine is already a popular therapy for recurrent pericarditis. It is also readily available in and outside of the hospital, and most clinicians have some familiarity with colchicine since it is used in other disease processes.
8.3
What barriers to implementation exist?
In patients who weigh over 70 kg and are intolerant of full-dose therapy (due to GI symptoms), a reasonable strategy would be to halve the dose, as if they weighed less than 70 kg. But patients who weigh less than 70 kg and cannot tolerate the half-dose strategy simply should not take colchicine.