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. Author manuscript; available in PMC: 2011 Aug 4.
Published in final edited form as: Aliment Pharmacol Ther. 2010 Mar 26;32(1):29–42. doi: 10.1111/j.1365-2036.2010.04315.x

Table 1. Variables assessed and recorded for each gastro-oesophageal reflux disease (GERD) trial.

Study design Study drug
Randomized, double-blinded study
Frequency of dosing
Study duration
Oesophageal pH measurement before enrollment
Endoscopic evaluation before enrollment
Presence of erosive esophagitis
Presence of run-in period
Frequency of office visits during active treatment
Frequency of office visits throughout entire study
Study population Total number of subjects in
 Placebo arm
 Active treatment arm
Total number of subjects who
 Completed placebo arm
 Completed active treatment arm
Mean age
Gender distribution
Heartburn response Reported relief of heartburn
Defined relief of heartburn as “complete relief of heartburn”
Quality measures (Jadad score) Was study described as randomized?
Was study described as double-blinded?
Were data on withdrawals and dropouts provided?
Was the method of randomization described and appropriate?
Was the method of blinding described and appropriate?