83 patients were randomized to receive either simethicone or placebo
for 3-10 days followed by crossover into opposite treatment group for
the next 3-10 days. Trial was a double blind, placebo controlled,
Inclusion criteria - Wessels definition for colic: "One who,
otherwise healthy and well-fed, has paroxysms of irritability, fussing
or crying for more than 3 hours a day and occurring on more than 3
days in any one week." In addition, patients had to be full
term, AGA, between 2-8 weeks of age, demonstrated weight gain of 5 or
more ounces per week, and normal history and physical.
Exclusion criteria: Prior to current diagnosis of illness, history
of treatment for hyperbilirubinemia, congenital or acquired abnormalities
which might predispose patient to irritability.
Outcome measured by daily diary recording childs diet, other medications
administered, number of episodes of colic, time of study medication
administration and parents assessment of symptoms (definitely
better, possibly better, same, possibly worse, definitely worse).
83 patients were randomized to two groups (simethicone or placebo).
Treatment lasted 3-10 days after which parents were to turn in medication
and get the opposite study medication. 25% of those treated with
simethicone reported definite or probable improvement. 29% of
those treated with placebo reported definite or probable improvement.
24% reported no change with either drug, 22% reported definite or probable
worsening with either drug.