Original Article
Treatment of postprandial discomfort syndrome in the elderly: a multi-centered prospective randomized controlled clinical study
Wang Gangshi, Xu Le, Chen Hongtan, Shi Liping, Huang Minjing, Xi Ling, Xu Lishu, Wang Fen, Li Hongyi, Li Shu, Zhang Yijun, Tan Shiyun, Hong Rutao, Lyu Nonghua, Ye Mei, Gan Huatian, Liu Miao, Wu Benyan, On behalf of Committee of Geriatric Gastroenterology, Chinese Society of Gastroenterology
Published 2020-02-01
Cite as Chin J Intern Med, 2020, 59(2): 117-123. DOI: 10.3760/cma.j.issn.0578-1426.2020.02.005
Abstract
ObjectiveTo 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.
MethodsA 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.
ResultsA 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.
ConclusionsThe 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.
Key words:
Dyspepsia; Aged; Postprandial discomfort syndrome; Oryz-Aspergillus enzyme and pancreatin tablet; Mosapride
Contributor Information
Wang Gangshi
Department of Gastroenterology, The Second Medical Center of PLA General Hospital, Beijing 100853, China
Xu Le
Department of Gastroenterology, Beijing Hospital, Beijing 100730, China
Chen Hongtan
Department of Gastroenterology, The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China
Shi Liping
Department of Geriatric Gastroenterology, Shaanxi Provincal People′s Hospital, Xi′an 710068, China
Huang Minjing
Department of Gastroenterology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China
Xi Ling
Department of Geriatrics, The First Hospital of Shanxi Medical University, Taiyuan 030001, China
Xu Lishu
Department of Geriatrics, Guangdong Provincal People′s Hospital, Guangzhou 510080, China
Wang Fen
Department of Gastroenterology, The Third Xiangya Hospital of Central South University, Changsha 410013, China
Li Hongyi
Department of Geriatrics, The Seventh Medical Center of PLA General Hospital, Beijing 100700, China
Li Shu
Department of Gastroenterology, Tianjin Medical University General Hospital, Tianjin 300052, China
Zhang Yijun
Department of Geriatric Gastroenterology, PLA Southern Theater General Hospital, Guangzhou 510010, China
Tan Shiyun
Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430060, China
Hong Rutao
Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China
Lyu Nonghua
Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang 330006, China
Ye Mei
Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan 430071, China
Gan Huatian
Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, China
Liu Miao
Department of Gastroenterology, The Second Medical Center of PLA General Hospital, Beijing 100853, China
Wu Benyan
Department of Gastroenterology, The Second Medical Center of PLA General Hospital, Beijing 100853, China
On behalf of Committee of Geriatric Gastroenterology, Chinese Society of Gastroenterology
