ABSTRACTS: Poster Session Abstracts
Introduction: Gastroesophageal reflux disease (GERD) afflicts 7% of infants. Major symptoms (Sx) are vomiting & crying, conceptualized as reflux of volume & acid, respectively, & thus responsive to prokinetic & anti-acid pharmacotherapy (Rx). This has prompted empiric Rx with both a prokinetic agent & an histamine-2 receptor antagonist, though limited prokinetic options now prompt empiric Rx with acid-suppression alone, without clearly documented efficacy. We compared, in a placebo (P) controlled trial, Sx response of infant esophagitis to 4m Rx with cimetidine 10mg/kg qid (Cm), cisapride 0.2mg/kg qid (Cs), both (B), or neither (N).
Methods: Subjects were 100 infants, 1–12m old, referred for GERD Sx July 1, 1994-October 13, 1999, with esophagitis on suction biopsy (Bx), parent consent, and no exclusions. Infants were randomly & blindly assigned to 1 of 4 arms; each took 2 “drugs”: Cm-P, Cs-P, Cm-Cs (i.e., B), or P-P (i.e., N). Sx (Infant Gastroesophageal Reflux Questionnaire, ©1992) & Bx were tested at 0m, 2m, 4m, 6m, & off protocol at 12m. At any visit with both Sx & Bx unimproved, infants were rescued to un-masked Cm-Cs, without un-masking prior Rx. At any visit with both Sx & Bx completely well, infants graduated off Rx. This analysis is Sx at 4m. Statistics chi square, Fischer’s exact, 2-tailed.
Results: Enrolled infants were aged 1–11.8m (median 3.5); 63% male; 88% Caucasian. After 4m blinded Rx, Sx became well on assigned Rx in only 15%. Although making up only 24% of enrolled infants, infants on dual placebo comprised 40% of those with resolved Sx (p=0.19 compared to other 3 groups combined). Rx with Both drugs together was less likely to result in withdrawal or rescue than other 3 groups combined (p<.05). Cm alone was more likely to result in withdrawal or rescue than other 3 groups combined (p<.05).
Conclusion: Efficacy of 4m of these pharmacotherapies for Sx of infant esophagitis is uncertain. Cimetidine used alone appears less effective &/or more aversive than all other 3 arms. Use of cimetidine & cisapride together may have protected against withdrawal or rescue, but Sx were completely well at 4m in a greater proportion of dual placebo babies than babies assigned other Rx (NS). Improvement in Sx with dual placebo may be due to the efficacy of “lifestyle modifications” used in all subjects, or to developmental maturation. All treatment trials for infant esophagitis should include placebo controls.