DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF RANITIDINE FOR GASTROESOPHAGEAL REFLUX SYMPTOMS DURING PREGNANCY

Objective: To determine whether ranitidine (Zantac) taken once or twic e daily is effective for relieving symptoms of gastroesophageal reflux among pregnant women who had failed conservative measures. Methods: V olunteers with heartburn despite antacids were sought among our obstet ric clinic population for this double-blind, placebo-controlled, tripl e crossover trial. After a baseline week, 20 patients were randomized to receive the three following weekly regimens: ranitidine 150 mg twic e daily, placebo in the morning and ranitidine 150 mg in the evening, or placebo twice daily. Daily scores on symptom diaries, global assess ments, and number of antacids taken were compared among the 18 patient s completing the study. Results: The twice-daily dosage of ranitidine was the only regimen found to reduce heartburn symptoms when compared with the baseline (P < .001) or a placebo (P < .01). Compared with ran itidine taken once daily, the twice-daily dosing prompted less need fo r antacid tablets compared with the placebo (P < .05 versus P > .05) a nd to the baseline (P < .001 versus P < .05). The average reduction of heartburn severity using twice-daily ranitidine was 55.6% when compar ed with baseline (95% confidence interval [CI] 34.8%, 76.5%) and was 4 4.2% when compared with placebo (95% CI 15.4%, 72.9%). Conclusion: Thi s study indicates the efficacy of ranitidine 150 mg taken twice daily, rather than once daily, for relief of gastroesophageal reflux symptom s during pregnancy. (C) 1997 by The American College of Obstetricians and Gynecologists.