P J Kahrilas1, M B Fennerty, B Joelsson. 1. Division of Gastroenterology and Hepatology, Northwestern University, Chicago, Illinois 60611, USA.
Abstract
OBJECTIVE:H2-receptor antagonists are commonly used as initial therapy in patients with gastroesophageal reflux disease (GERD) and are frequently continued at the same or higher doses when symptoms persist after 4-6 wk of therapy. Our objective was to compare the efficacy of twice-daily treatment with either ranitidine 150 mg b.i.d. or 300 mg b.i.d. in resolving heartburn in GERD patients who remained symptomatic after 6 wk of therapy withranitidine 150 mg b.i.d. METHODS: This was a two-phase, prospective study. In the first phase, GERD patients with heartburn on > or = 4 of the 7 days before entry were treated withopen-label ranitidine 150 mg b.i.d. for 6 wk. In the second phase, patients who were still symptomatic were randomized to 8 wk of double-blind ranitidine therapy at either the same (150 mg b.i.d.) or a higher dose (300 mg b.i.d.). The primary efficacy variable was the resolution of heartburn at wk 4 and 8, as monitored through diary cards. RESULTS: Of the 481 patients treated for 6 wk in phaseI, 285 (59%) were still symptomatic; 271 patients (95% of those still symptomatic) were randomized to double-blind treatment with ranitidine. In phase II, 45% of the patients in each treatment group experienced no more than mild heartburn; complete heartburn resolution was observed in <20% of patients in either group at wk 4 and 8. There were no significant differences in efficacy between the two treatment groups. CONCLUSIONS: These results indicate that the majority of GERD patients still have symptoms of heartburn after 6 wk of ranitidine therapy. Only a minority of these patients experience complete relief of heartburn after an additional 8 wk of treatment, which demonstrates that doubling the dose of ranitidine is not efficacious.
RCT Entities:
OBJECTIVE: H2-receptor antagonists are commonly used as initial therapy in patients with gastroesophageal reflux disease (GERD) and are frequently continued at the same or higher doses when symptoms persist after 4-6 wk of therapy. Our objective was to compare the efficacy of twice-daily treatment with either ranitidine 150 mg b.i.d. or 300 mg b.i.d. in resolving heartburn in GERDpatients who remained symptomatic after 6 wk of therapy with ranitidine 150 mg b.i.d. METHODS: This was a two-phase, prospective study. In the first phase, GERDpatients with heartburn on > or = 4 of the 7 days before entry were treated with open-label ranitidine 150 mg b.i.d. for 6 wk. In the second phase, patients who were still symptomatic were randomized to 8 wk of double-blind ranitidine therapy at either the same (150 mg b.i.d.) or a higher dose (300 mg b.i.d.). The primary efficacy variable was the resolution of heartburn at wk 4 and 8, as monitored through diary cards. RESULTS: Of the 481 patients treated for 6 wk in phase I, 285 (59%) were still symptomatic; 271 patients (95% of those still symptomatic) were randomized to double-blind treatment with ranitidine. In phase II, 45% of the patients in each treatment group experienced no more than mild heartburn; complete heartburn resolution was observed in <20% of patients in either group at wk 4 and 8. There were no significant differences in efficacy between the two treatment groups. CONCLUSIONS: These results indicate that the majority of GERDpatients still have symptoms of heartburn after 6 wk of ranitidine therapy. Only a minority of these patients experience complete relief of heartburn after an additional 8 wk of treatment, which demonstrates that doubling the dose of ranitidine is not efficacious.