[Efficacy of domperidone and pyridostigmine in the treatment of patients with functional dyspepsia: a randomized clinical trial]

ABSTRACT

The majority of dyspeptic patients do not have identifiable disease, which is also known as functional dyspepsia. The therapeutic approach to patients with functional dyspepsia is still a matter of debate; prokinetic agents are commonly used for symptom relief. This study aims to evaluate the efficacy of domperidone and pyridostigmine [an inhibitor of cholinesterase] in patients with functional dyspepsia. This was a single-blind, randomized clinical trial performed on 117 patients [December 2007 to November 2009] diagnosed with functional dyspepsia according to ROME II criteria. The effects of 4 weeks of treatment with domperidone [10 mg tid], yridostigmine [60 mg tid], and placebo were compared. We scored each patient according to VAS to rank the severity of 8 different upper GI symptoms [epigastric fullness, early satiety, gnawing, nausea, vomiting, belching, bloating, and epigastric pain] both before and at the end of treatment. Data were entered into SPSS software version 16 and analyzed. P<0.05 was considered significant. At the end of treatment, the total dyspeptic symptom score decreased from 24 to 13. According to ANOVA, there were significant differences between the 3 groups in 3 out of 8 symptom scores of bloating [p=0.039], early satiety [p=0.006], and nausea [p=0.016]. The post hoc test determined that domperidone was more effective than pyridostigmine and placebo in improvement of early satiety [p=0.038 and p=0.014, respectively]. Domperidone was more effective than pyridostigmine in the control of nausea [p=0.024]. Domperidone [p=0.023] and pyridostigmine [p=0.042] were superior in relieving bloating symptoms compared to placebo. Overall, in the control of GI symptoms domperidone was more effective than placebo [p=0.045]. domperidone and pyridostigmine are useful in improving bloating, early satiety, and nausea. However they are similar to placebo in controlling epigastric pain, fullness, belching and gnawing