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KMID : 0378020010440030017
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New Medical Journal
2001 Volume.44 No. 3 p.17 ~ p.23
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The effect of Levosulpiride (Levopride®) on Gastric Emptying Time and Symptoms in Patients with Functional Gastrointestinal disorders
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Kim Yong-Tae
Yoon Yong-Bum
Song In-Sung
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Abstract
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Background : Though many patients are suffering from functional gastrointestinal disorders, there is no drug that showed sufficient effect and safety. Levosulpiride (Levopride®) is an L-isomer of sulpiride which antagonizes dopaminergic receptors in gastrointestinal tract and central nervous system.
Aims : This study was undertaken to evaluate the effect of Levopride® on the gastric emptying time and symptom scores in patients with functional upper gastrointestinal disorders.
Methods : A tatal 49 patients with upper gastrointestinal symptoms without organic diseases were enrolled in this study. They are randomly divided into two groups, treatment group (n=24) and control group (n=25). Treatment group received Levopride® 25mg t.i.d. daily for 3 weeks and control group took placebo. Symptom scores of nausea, vomiting, postprandial discomfort, abdominal fullness, epigastric pain, soreness, anorexia, reflux, and belching were recorded daily before and during the treatment. Gastric emptying time, liver function test, peripheral blood cell count and urine analysis were tested before and after treatment. All side effects were also recorded during the Levopride® treatment.
Result : There were no difference in age, sex ratio, symptom score and gastric emptying between the two groups before Levopride® administration. In the treatment group, symptoms score of reflux decreased from 1.6±0.54 of pre-treatment to 0.2?0.44 of post-treatment (p=0.042) but not in the control group (from 2.00±1.00 to 1.66±0.57, p=0.85). Though the severity of other symptoms also decreased in the treatment group after Levopride® treatment, there were no significant differences between the two groups because these symptoms improved also in the control group even after placebo administration. T1/2 of gastric emptying time of the treatment and control group were 122.8±51.9 min. and 127.2±111.6 min, respectively. It decreased significantly more in the treatment group (104.0±40.5 min.) than in the control group (121.0±85.3 min.) after drug administration (p=0.04). One patient in treatment group complained of mind extrapyramidal symptoms.
Conclusion : Levopride® is effective and safe in improving symptoms especially of reflux in patients with functional upper gastrointestinal disorders by shorting gastric emptying time.
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KEYWORD
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Functional gastrointestinal disorders, Gastric emptying time, Levosulpiride
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