A double-blind multicenter comparison of domperidone and metoclopramide in the treatment of diabetic patients with symptoms of gastroparesis.
OBJECTIVE
A double-blind, multicenter, randomized trial was conducted to compare the side effects and efficacy of domperidone and metoclopramide in symptomatic diabetic gastroparesis.


METHODS
Ninety-three insulin-dependent diabetes patients with a > or = 3-month history of gastroparesis symptoms were recruited; 48 received domperidone 2 x 10-mg tablets 4 times daily, and 45 received metoclopramide 1 x 10-mg tablet + 1 placebo tablet 4 times daily. Nausea, vomiting, bloating/distension, and early satiety were evaluated for severity after 2 and 4 wk. Adverse central nervous system (CNS) effects of somnolence, akathisia, asthenia, anxiety, depression, and reduced mental acuity were elicited and graded for severity at 2 and 4 wk.


RESULTS
Domperidone and metoclopramide were equally effective in alleviating symptoms of diabetic gastroparesis. Elicited adverse CNS effects were more severe and more common with metoclopramide. Somnolence was acknowledged by 49% of patients (mean severity score, 1.03) after 4 wk of metoclopramide compared with 29% of patients (mean severity score, 0.49) after 4 wk of domperidone (incidence, p = 0.02; severity; p = 0.03). A reduction in mental acuity was acknowledged by 33% of patients (mean severity score, 0.62) after 4 wk of metoclopramide, compared with 20% of patients (mean severity score, 0.27) after 4 wk of domperidone (incidence, p = 0.04; severity, p = 0.04). Akathisia, asthenia, anxiety, and depression were also acknowledged less often, and at a lower severity, after 4 wk of domperidone, although these differences were not statistically significant.


CONCLUSIONS
Domperidone and metoclopramide effectively reduce the symptoms of diabetic gastroparesis; CNS side effects are more pronounced with metoclopramide.
Patterson
D
D
Virginia Mason Clinic Hospital, Seattle, Washington 98101, USA.
Abell
T
T
Rothstein
R
R
Koch
K
K
Barnett
J
J
D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications*; D004294:Domperidone / Q000009:adverse effects / Q000627:therapeutic use*; D018492:Dopamine Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D018589:Gastroparesis / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D008297:Male; D008787:Metoclopramide / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged
D000932:Antiemetics; D018492:Dopamine Antagonists; D004294:Domperidone; D008787:Metoclopramide