Abstract
and symptoms while subjects were at their highest dose (last 7 days of treatment period) versus placebo, adjusting for corresponding baseline values. Results. All 30 patients completed the study. 15 pts (7P, 8 PLA) had moderately severe autonomic neuropathy. P was well tolerated; mild-moderate, predominantly cholinergic side effects, were more common (p = 0.07) with P (11pt) than placebo (5pt). Compared to placebo, P accelerated colonic transit (GC24, p = 0.004), increased stool frequency (p = 0.02), reduced stool consistency (p= 0.004), and improved ease of passage (p=0.04). However, no significant treatment effects relative to placebo were detected in gastric emptying or small intestinal transit. Conclusions. P accelerated colonic transit and improved bowel symptoms in constipated patients with diabetes mellitus. Longer studies evaluating the effects of P on symptoms in DM and constipation are necessary. Supported by PO1 DK68055.
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