Abstract | BACKGROUND: METHODS: A 14-day multicentre randomised double-blind double-dummy non-inferiority trial compared Gaviscon® (4 × 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. RESULTS: 278 patients were recruited; 120 were included in the Gaviscon® 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® 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. CONCLUSION: Gaviscon® 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. TRIAL REGISTRATION: ISRCTN62203233.
|
Authors | Denis Pouchain, Marc-André Bigard, François Liard, Marc Childs, Annick Decaudin, Donna McVey |
Journal | BMC gastroenterology
(BMC Gastroenterol)
Vol. 12
Pg. 18
(Feb 23 2012)
ISSN: 1471-230X [Electronic] England |
PMID | 22361121
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Alginates
- Drug Combinations
- Proton Pump Inhibitors
- Silicic Acid
- Aluminum Hydroxide
- alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
- Sodium Bicarbonate
- Omeprazole
|
Topics |
- Adolescent
- Adult
- Alginates
(adverse effects, therapeutic use)
- Aluminum Hydroxide
(adverse effects, therapeutic use)
- Double-Blind Method
- Drug Combinations
- Female
- Gastroesophageal Reflux
(drug therapy, prevention & control)
- Humans
- Male
- Middle Aged
- Omeprazole
(adverse effects, therapeutic use)
- Proton Pump Inhibitors
(adverse effects, therapeutic use)
- Severity of Illness Index
- Silicic Acid
(adverse effects, therapeutic use)
- Sodium Bicarbonate
(adverse effects, therapeutic use)
- Time Factors
- Treatment Outcome
- Young Adult
|