Gaviscon(R) vs. Omeprazole in symptomatic treatment of moderate gastroesophageal reflux. A direct comparative randomised trial
BMC Gastroenterology, 02/24/2012
Pouchain D et al. – Gaviscon(R) was non–inferior to omeprazole in achieving a 24–h heartburn–free period in moderate episodic heartburn, and is a relevant effective alternative treatment in moderate GERD in primary care.
A 14–day multicentre randomised double–blind double–dummy non–inferiority trial compared Gaviscon(R) (4 x 10 mL/day) and omeprazole (20 mg/day) in patients with 2–6 day heartburn episodes weekly without alarm signals.
The primary outcome was the mean time to onset of the first 24–h heartburn–free period after initial dosing.
Secondary outcomes were the proportion of patients without heartburn by D7, pain relief by D7, and reduction in pain intensity by D7 and D14.
278 patients were recruited; 120 were included in the Gaviscon(R) group and 121 in the omeprazole group for the per protocol non–inferiority analysis.
The mean time to onset of the first 24–h heartburn–free period after initial dosing was 2.0 (+/–2.2) days for Gaviscon(R) and 2.0 (+/–2.3) days for omeprazole (p = 0.93); mean intergroup difference was 0.01 +/– 1.55 days (95% CI = 0.41 to 0.43): i.e., less than the lower limit of the 95% CI of 0.5 days predetermined to demonstrate non–inferiority.
The mean number of heartburn–free days by D7 was significantly greater in the omeprazole group: 3.7 +/– 2.3 days vs. 3.1 +/– 2.1 (p = 0.02).
On D7, overall quality of pain relief was slightly in favour of omeprazole (p = 0.049).
There was no significant difference in the reduction in pain intensity between groups by D7 (p = 0.11) or D14 (p = 0.08).
Tolerance and safety were good and comparable in both groups.
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