Effects of levosulpiride in patients with functional dyspepsia accompanied by delayed gastric emptying.

OBJECTIVES: Levosulpiride is the levo-enantiomer of sulpiride, a well-known antiemetic, antidyspeptic and antipsychotic drug. This study was undertaken to investigate the effects of levosulpiride on dyspeptic symptoms and gastric motor function in a group of patients with functional dyspepsia showing delayed gastric emptying. METHOD: Forty two eligible patients were entered into a 3 week, double-blind randomized comparison of 25mg of levosulpiride or placebo t.i.d.. Symptom assessment and gastric scintigraphy following the intake of scrambled egg sandwich, were performed in each patient before and after treatment. RESULTS: The improvement of symptom score in levosulpiride group was higher than the placebo group (p < 0.05). We assessed global efficacy, which was excellent in 1 (6%), good 11 (65%), fair 4 (24%), nil 1 (6%) of those receiving levosulpiride, and fair 9 (60%), nil 5 (33%), poor 1 (6%) of those receiving placebo. Levosulpiride tended to be more effective than placebo in relieving the dyspeptic symptoms especially in the subgroups of dysmotility-like (p < 0.05) and nonspecific (p < 0.05) as compared to other subgroups (p = 0.16). The reduction of gastric emptying time after levosulpiride treatment was more marked than Placebo group (p < 0.05). We found a significant correlation between changes of symptom score and gastric emptying time (r = 0.47, p = 0.01). No serious adverse effects were reported after administration of either levosulpiride or placebo. Only two patients reported mild somnolence during levosulpiride administration. CONCLUSIONS: Levosulpiride is effective and well tolerated in patients with functional dyspepsia accompanied by delayed gastric emptying. Its efficacy may be related to its action on the gastric motor function by improving the delayed gastric emptying.