A systematic review of the efficacy of domperidone for the treatment of diabetic gastroparesis.
OBJECTIVE
Despite being widely used in more than 20 countries for the treatment of diabetic gastroparesis for several decades, domperidone is approved only on an investigational basis in the United States. However, because its use is increasing, it is important for gastroenterologists in this country to understand its effectiveness in this condition. The literature on this subject varies considerably with respect to the methods and outcome measures, making a meta-analysis unfeasible.


METHODS
Our objective was to systematically analyze studies of the efficacy of domperidone in diabetic gastroparesis, with a focus on their methodologic and scientific merit. Information from 28 trials (11 full articles and 17 abstracts) from 1981 to 2007 was analyzed.


RESULTS
The average study quality score was 8.3 out of a possible 15 and the total sample size equaled 1016. Overall, 64% of the studies showed significant efficacy of domperidone on the improvement of symptoms. Sixty percent of the studies showed an efficacy in gastric emptying and 67% of the studies proved the drug effective in reducing hospital admissions.


CONCLUSIONS
Overall, our assessment is that there is level 3 evidence for the efficacy of domperidone in diabetic gastroparesis, leading to a grade C recommendation for its use in this condition. These results need to be interpreted very cautiously because of significant methodologic limitations of these studies, including the fact that most positive studies lacked a control arm. It is clear that larger and better-designed studies are needed to further validate the use of this drug in diabetic gastroparesis.
Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Aravind
A
Sugumar
Amanpal
A
Singh
Pankaj Jay
PJ
Pasricha
D002986:Clinical Trials as Topic; D048909:Diabetes Complications; D004294:Domperidone / Q000627:therapeutic use*; D018589:Gastroparesis / Q000188:drug therapy*; D006801:Humans; D016896:Treatment Outcome; D014481:United States
D004294:Domperidone