Intravenous Famotidine vs Oral Maalox for Treatment of Dyspepsia in the Emergency Department: A Pilot Study

Dyspepsia is a common chief complaint leading to considerable pain and discomfort. To our knowledge, no prior study has compared the efficacy of oral antacids and intravenous (IV) histamine-2 blockers in ED patients despite their frequency of use. In this pilot study we tested the study feasibility and analgesic efficacy of oral Maalox versus IV famotidine. We also tested the hypothesis that Maalox would result in a 1.5-point greater reduction in pain scores on an 11-point verbal numerical scale (VNS) over one hour when compared to IV Famotidine in ED patients with dyspepsia.

Prior to conducting a large RCT, we conducted a pilot feasibility study in which adult ED patients with dyspepsia and a VNS score of 3 or greater on an 11 point scale of 0 to 10 (from none to worst) were randomized to oral Maalox 60 ml, or IV Famotidine 20 mg. Pain scores were recorded at 0, 15, 30, 45, and 60 minutes after administration of the assigned drug. We used a linear mixed-effect model to compare pain scores over time and between groups. Percentages of rescue medications and future patient recommendations were compared with Fisher’s exact test.

22 patients were randomized to famotidine (10) or Maalox (12). Mean (SD) age was 37.4 (14.5), 68% were female, 63.6% were white, 27.3% were Hispanic. There was no significant between group differences in baseline characteristics. Median (IQR) initial pain scores were 5 (4-6) and 6 (5-7) in the Famotidine and Maalox groups respectively (adjusted P=0.99). There were no significant between group and within group differences in pain scores over time (adjusted P values all >0.05). 77.8% of patients in the Famotidine group and 70.0% of patients in the Maalox group required rescue medication (P>0.99). 60% of patients who received Famotidine and 45.5% of patients who received Maalox said they would like to be treated with the same drug again if experiencing similar symptoms (P=0.67).

This pilot study confirmed the feasibility of a RCT. There were no significant within group or between group differences in pain scores in adult ED patients with dyspepsia randomized to oral Maalox or IV Famotidine. Therefore, our results do not support the study hypothesis that Maalox is superior to Famotidine by at least 1.5 points.