A double-blind multicenter comparison of domperidone and metoclopramide inthe treatment of diabetic patients with symptoms of gastroparesis

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.