Efficacy of Domperidone and Pyridostigmine in the Treatment of Patients with Functional Dyspepsia: A Randomized Clinical Trial

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), pyridostigmine (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.