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Objective@#To evaluate the efficacy and safety of Oryz-Aspergillus enzyme and pancreatin tablets (Combizym®) in the treatment of postprandial distress syndrome (PDS) in the elderly, compared with gastrointestinal motility drugs.@*Methods@#A prospective randomized controlled trial was designed and registered in the China Clinical Trials Registry (ChiCTR-IPR-16008185). The elderly patients with PDS were randomly divided into three groups, including Mosapride group with Mosapride citrate tablets 5 mg 3 times per day for 2 weeks; Combizym® group with Combizym tablets 244 mg 3 times per day for 2 weeks; combined treatment group with both drugs and same doses for 2 weeks. The modified Nepean dyspepsia index (NDSI) score, discomfort intensity score and PDS score were calculated on patients before treatment, at the end of first and second week of treatment, as well as 4 weeks after treatment finished, respectively. Adverse effects were evaluated.@*Results@#A total of 323 patients from 16 tertiary hospitals in China were enrolled in this study. Among them, 105 patients were in Mosapride group, 109 in Combizym® group and 109 in combined treatment group. There were 148 males (45.8%) and 175 females (54.2%) with median age 71.4±9.0 years (60-100 years). Baseline characteristics of three groups were comparable. After treatment, the NDSI scores in three groups all decreased significantly (P<0.001), while they were similar between groups (P>0.05). The discomfort intensity score and PDS score in three groups showed a significant reduction after treatment (P<0.001), especially in the combined treatment group. Compared with Mosapride group, the scores in Combizym® group decreased significantly after one or two weeks [discomfort intensity score: after one week, 4.0(2.5, 8.0) vs. 6.0(3.0, 10.0); after two weeks, 3.0(0.0, 5.0) vs. 4.0(2.0, 6.0); all P<0.05. PDS score: after one week, 6.0(3.0, 9.0) vs. 7.0(3.5, 10.5); after two weeks, 3.0(0.0, 5.0) vs. 4.0(2.0, 7.0); all P<0.05]. The efficacy rate in all patients after first week of treatment was over 15.0%. The efficacy rates after two weeks were 55.2%, 68.8% and 73.4% in Mosapride group, Combizym® group and combined treatment group, respectively. After two week treatment, the efficacy rates in Combizym® group (P=0.041) and combined group (P=0.006) were higher than that of Mosapride group. The recurrence rate of Mosapride group was 9.5%, which was significantly higher than that of Combizym® group (1.8%, P<0.05) and combined treatment group (1.8%, P<0.05). There were no serious adverse effects in the three groups.@*Conclusions@#The efficacy of Oryz-Aspergillus enzyme and pancreatin tablets is comparable with that of Mosapride in elderly PDS patients, with fewer adverse effects and low recurrence rate. Combination regimen indicates better efficacy than that of Oryz-Aspergillus enzyme and pancreatin tablets or Mosapride alone.
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Background:Oryz-Aspergillus Enzyme and Pancreatin Tablet is a double-deck digestive enzyme pellet containing Oryz-Aspergillus enzyme and pancreatin that has been widely used for treatment of functional dyspepsia (FD)in clinical practice. However,there is no randomized controlled trial focusing on the efficacy of this agent versus other drugs used for treatment of FD such as prokinetics and proton pump inhibitors (PPI). Aims:To compare the efficacy and safety among Oryz-Aspergillus Enzyme and Pancreatin Tablet,Domperidone Tablet and Esomeprazole Magnesium Enteric-coated Tablet, three drugs with different mechanisms of action on FD,in Chinese population. Methods:A total of 82 Helicobacter pylori-negative outpatients fulfilling the diagnostic criteria of FD in Rome Ⅲ were recruited from Nov. 2015 to Jun. 2016 at the First Affiliated Hospital of Zhejiang Chinese Medical University. These patients were randomly allocated into 3 groups,and received Oryz-Aspergillus Enzyme and Pancreatin Tablet (group A),Domperidone Tablet (group B)and Esomeprazole Magnesium Enteric-coated Tablet (group C)orally for 4 weeks,respectively. The improvement of dyspeptic symptoms and adverse events were observed and recorded. Results:After 4 weeks treatment,the overall efficacies for global symptoms in group A,group B and group C were 93. 1%,88. 9% and 69. 2%,respectively,statistically significant difference was existed among the three groups (P < 0. 05). Domperidone Tablet was effective for postprandial fullness and early satiety;Esomeprazole Magnesium Enteric-coated Tablet was sensitive for epigastric pain,epigastric burning,and belching and regurgitation;the efficacies of Oryz-Aspergillus Enzyme and Pancreatin Tablet for all five dyspeptic symptoms were in between. No adverse events were observed during treatment course. Conclusions:Digestive enzymes,prokinetics and PPI have different sensitive symptoms and optimal indications for treatment of FD. The overall efficacy of Oryz-Aspergillus Enzyme and Pancreatin Tablet is superior to that of prokinetics and PPI.