Diabetic gastropathy and prokinetics.

The treatment of diabetic gastropathy, which here refers to a clinical syndrome of upper GI tract symptoms suggestive of an upper motility disturbance in diabetes whether or not there is delayed gastric emptying, remains suboptimal. New prokinetics and other motility-modifying agents may prove useful, but adequate clinical trials will be required to establish a role for them. However, diabetic gastropathy seems to represent a heterogenous syndrome in terms of pathophysiology, which potentially complicates the design of new randomized, controlled trials. This review aims to provide guidelines for future trials in this field. The evidence that delayed gastric emptying is a cause of symptoms in diabetic gastropathy is critically evaluated. The trial evidence supporting the short and long term efficacy of prokinetics is reviewed. Based on the available literature, it is concluded that improvement in gastric emptying does not equate with symptom relief in diabetic gastropathy. It is suggested that although gastric emptying should still be measured in clinical trials, it should not represent the primary outcome. The withdrawal treatment design applied in studies of diabetic gastropathy might be suboptimal. Double blind, parallel group studies remain the trial design of choice, but incorporation of validated outcome assessments and measurement of potential confounders of treatment response need attention in future trials.