ABSTRACT
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.