D. Patterson et al., A double-blind multicenter comparison of domperidone and metoclopramide inthe treatment of diabetic patients with symptoms of gastroparesis, AM J GASTRO, 94(5), 1999, pp. 1230-1234
OBJECTIVE A double-blind, multicenter, randomized trial was conducted to co
mpare the side effects and efficacy of domperidone and metoclopramide in sy
mptomatic diabetic gastroparesis.
METHODS: Ninety-three insulin-dependent diabetes patients with a greater th
an or equal to 3-month history of gastroparesis symptoms were recruited; 48
received domperidone 2 x 10-mg tablets 4 times daily, and 45 received meto
clopramide 1 x 10-mg tablet + 1 placebo tablet 4 times daily. Nausea, vomit
ing, bloating/distension, and early satiety were evaluated for severity aft
er 2 and 4 wk. Adverse central nervous system (CNS) effects of somnolence,
akathisia, asthenia, anxiety, depression, and reduced mental acuity were el
icited and graded for severity at 2 and 4 wk.
RESULTS: Domperidone and metoclopramide were equally effective in alleviati
ng symptoms of diabetic gastroparesis. Elicited adverse CNS effects were mo
re severe and more common with metoclopramide. Somnolence was acknowledged
by 49% of patients (mean severity score, 1.03) after 4 wk of meloclopramide
compared with 29% of patients (mean severity score, 0.49) after 4 wk of do
mperidone (incidence, p = 0.02; severity; p = 0.03). A reduction in mental
acuity was acknowledged by 33% of patients (mean severity score, 0.62) afte
r 4 wk of metoclopramide, compared with 20% of patients (mean severity scor
e, 0.27) after 4 wk of domperidone (incidence, p = 0.04; severity, p 0.04).
Akathisia, asthenia, anxiety, and depression were also acknowledged less o
ften, and at a lower severity, after 4 wk of domperidone, although these di
fferences were not statistically significant.
CONCLUSIONS: Domperidone and metoclopramide effectively reduce the symptoms
of diabetic gastroparesis; CNS side effects are more pronounced with metoc
lopramide. (C) 1999 by Am. Cell. of Gastroenterology.