OBJECTIVE: H-2 receptor antagonist therapy has been shown to produce reboun
d acid hypersecretion. The clinical significance of this phenomenon is not
known. We performed this study to determine whether withdrawal of H-2 recep
tor antagonist therapy results in dyspepsia in previously asymptomatic volu
nteers.
METHODS: Thirty-five Helicobacter pylori-positive asymptomatic volunteers w
ere randomized in double-blind fashion to receive 2 months' treatment with
either ranitidine 300 mg nocte or placebo. Dyspeptic symptoms were measured
before starting treatment and over the course of 10 days after stopping tr
eatment by means of a validated questionnaire.
RESULTS: Thirty-one subjects completed the study; 17 were randomized to ran
itidine. The pretreatment median aggregate dyspepsia score of the placebo g
roup was 0 (0-4), as was that of the ranitidine group (0-8) (N.S.). During
the 10 days after completion of ranitidine, the median aggregate dyspepsia
score was 1.4 (0-30), compared with 0 (0-6.3) after placebo (p < 0.01). Of
those given ranitidine, 59% experienced dyspepsia after treatment, compared
with only 14% who took placebo. In the subgroup that developed dyspepsia a
fter active therapy, the median duration of symptoms was 2 days, symptom se
verity being maximal on the second day after completion of the tablets. On
the days when dyspepsia was experienced, the median daily dyspepsia score w
as 5 (range, 2-10), which was similar to that of a control group with activ
e duodenal ulcer disease (5; range, 0-11).
CONCLUSIONS: Withdrawal of a 2-month course of ranitidine 300 mg nocte resu
lts in the development of dyspeptic symptoms in a proportion of previously
asymptomatic subjects. Patients receiving ranitidine should be warned about
this rebound dyspepsia and advised not to immediately resume treatment, as
rebound symptoms are likely to improve within a few days. (C) 1999 by Am.
Cell. of Gastroenterology.