Randomised control trial
Berman, Dean, Porter, Robert, Graber, MylissaThe GI Cocktail is no more effective than plain liquid anacid: randomized, double blind clinical trial
Journal of Emergency Medicine
25(3): 239-244, 2003 October
- Submitted by:Jason BOWMAN - EMERGENCY MEDICINE RESIDENT
- Institution:merc
- Date submitted:10th May 2006
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
yes
2
Design
2.1
Is the study design suitable for the objectives
yes
2.2
Who / what was studied?
pain relief from GI cocktail versus Antacids alone
2.3
Was this the right sample to answer the objectives?
yes, ED patients with dyspepsia
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
yes
2.5
Were all subjects accounted for?
yes
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?
no placebo arm
2.9
How was randomisation carried out?
computerised generated randomization
2.10
Are the outcomes clinically relevant?
partially, cost and side effects of the lidocaine and donnatal are minimmal
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
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?
no
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?
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)
1B
7.3
Does this paper help me answer my problem?
yes
8
Implementation
8.1
Can any necessary change be implemented in practice?
Yes, Only using maalox or any antacid instead of the GI cocktail mixture
8.2
What aids to implementation exist?
Low cost of therapy with antacids. Hospitals are already stocked and are currently being used
8.3
What barriers to implementation exist?
Low cost and low incidense of side-effects of lidocaine and donnatal in GI cocktails. Difficulty in changing mindset of the " GI Cocktail".