Objective: The objective of this study was to evaluate
clinical improvement and safety with use of cyproheptadine in
functional gastrointestinal disorders (FGIDs) in children.
Methods: Retrospectively evaluating the efficacy and
safety of the use for indications including Rome III–defined FGIDs:
functional abdominal pain, functional dyspepsia, irritable bowel
syndrome (IBS), abdominal migraine, cyclic vomiting syndrome. Response
categories were as follows: no improvement group/partial improvement
group; requiring intervention, or complete improvement group (CIG);
warranting discontinuation; ongoing use; or parental unwillingness to
stop medication.
Results: Among 307 patients, 151 included; 58% girls,
ages 1 to 18 years (median 9); 110 (72.8%) reported complete symptom
improvement; 41 (27.2%) reported no or partial improvement. Mean initial
and final doses in the CIG were 4.85 mg/day (0.14 mg · kg−1 · day−1) and 5.34 mg/day (0.14 mg · kg−1 · day−1),
respectively. A total of 102/151 (68%) reported no adverse effects.
Adverse effects shown were as sleepiness in 19/151 (13%) and weight gain
in 15/151 (10%). Cyproheptadine was effective in improving symptoms of
functional abdominal pain, functional dyspepsia, in a relatively larger
number of patients. Patients in smaller numbers had significant
improvement 13/18 (72%) abdominal migraine, 10/10 (100%) IBS, and 6/8
(75%) cyclic vomiting syndrome. This is the first time report of
improvement in IBS. Other pharmacodynamics had been as follows: the
lower the body weight, the higher are the odds of no to partial
improvement; patients in no improvement group/partial improvement group
experience more adverse effects as compared to the CIG; the single best
predictor of clinical improvement was body mass index. A 1 unit increase
in body mass index with cyproheptadine use increased the odds of
clinical improvement by 1.5-fold (P = 0.01).
Conclusions: Cyproheptadine effectively improves
symptoms of Rome III–defined FGIDs and has a good safety profile when
used for these indications.
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