Pj. Kahrilas et al., High- versus standard-dose ranitidine for control of heartburn in poorly responsive acid reflux disease: A prospective, controlled trial, AM J GASTRO, 94(1), 1999, pp. 92-97
Objective: H-2-receptor antagonists are commonly used as initial therapy in
patients with gastroesophageal reflux disease (GERD) and are frequently co
ntinued at the same or higher doses when symptoms persist after 4-6 wk of t
herapy. 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 heartbur
n in GERD patients who remained symptomatic after 6 wk of therapy with rani
tidine 150 mg b.i.d. Methods: This was a two-phase, prospective study, In t
he first phase, GERD patients with heartburn on greater than or equal to 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 we
re 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 var
iable was the resolution of heartburn at wk 4 and 8, as monitored through d
iary 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 hear
t-burn; complete heartburn resolution was observed in < 20% of patients in
either group at wk 4 and 8, There were no significant differences in effica
cy between the two treatment groups. Conclusions: These results indicate th
at the majority of GERD patients still have symptoms of heartburn after 6 w
k of ranitidine therapy. Only a minority of these patients experience compl
ete relief of heartburn after an additional 8 wk of treatment, which demons
trates that doubling the dose of ranitidine is not efficacious. (C) 1999 by
Am. Cell. of Gastroenterology.