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.Methods
- 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.