Effects of Levosulpiride in Patients with Functional Dyspepsia Accompanied by Delayed Gastric Emptying

Abstract

ObjectivesLevosulpiride 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.MethodForty 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.ResultsThe 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.ConclusionsLevosulpiride 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.

Randomized Double Blind Placebo Controlled Trial to Assess the Efficacy and Tolerability of Levosulpiride in Dysmotility Type of Functional Dyspepsia

“…13,14 In this study, we found another finding that statistically significant improvement in symptom score occurred in Placebo group also. This result was supported by Fermin Mearin et al study, which has found that symptomatic response to Placebo is substantial in functional dyspepsia and clinical improvement might occur independently of detectable changes in the gastroduodenal motor activity or gastric hypersensitivity.…”

Treatment of functional dyspepsia with antianxiety or antidepressive agents: systematic review

“…14-18 Combination therapies were used in 3 trials. [19][20][21] In 11 [9][10][11][13][14][15][16][17][18][19]21 of the 13 studies, dyspeptic symptoms were improved significantly by treatment. Significant improvement was observed in 2 of 3 studies 9,19,20 using antianxiety agents singly or with the combined use of an anticholinergic agent.…”

“…Finally, 13 articles that included information on a total of 1717 patients were selected according to the inclusion criteria (Table 1). [9][10][11][12][13][14][15][16][17][18][19][20][21] Seventy-seven articles were excluded. The main reasons for exclusion were that the articles were review articles, pertained to children, or were concerned with dyspepsia as a side effect or dyspepsia accompanied by other diseases.…”

“…The diagnostic criteria of FD in 9 articles 10,11,[13][14][15][16][17][18]21 either fulfilled or resembled the Rome criteria for FD, 22,23 and reflux type-FD was included in 2 articles. 16,18 In 4 articles, 9,12,19,20 the diagnostic criteria of FD were obscure. Three articles 11,19,20 included patients with IBS symptoms as well as FD symptoms.…”

Efficacy and Tolerability of Levosulipride, Domperidone and Metoclopramide in Patients with Non-Ulcer Functional Dyspepsia: A Comparative Analysis

“…Among prokinetic drugs, numerous clinical studies have offered facts on the efficacy of dopamine receptor antagonists such as Metoclopramide, Domperidone and Levosulpiride in the treatment of functional dyspepsia [9]. Metoclopramide, Domperidone and Levosulpiride have both antiemetic and prokinetic properties since they antagonize dopamine receptors in the central nervous system as well as in the gastrointestinal tract where dopamine apply compelling inhibitory effects on motility [10].…”