Treatment of postprandial discomfort syndrome in the elderly: a multi-centered prospective randomized controlled clinical study

Gangshi Wang; Le XU; Hongtan Chen; Liping Shi; Minjing Huang; Ling XI; Lishu XU; Fen Wang; Hongyi LI; Shu LI; Yijun Zhang; Shiyun Tan; Rutao Hong; Nonghua Lyu; Mei YE; Huatian Gan; Miao Liu; Benyan WU

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Treatment of postprandial discomfort syndrome in the elderly: a multi-centered prospective randomized controlled clinical study

VernacularTitle: 老年人餐后不适综合征的治疗：一项多中心前瞻性随机对照临床研究
Author: Gangshi WANG ¹ ; Le XU ² ; Hongtan CHEN ³ ; Liping SHI ⁴ ; Minjing HUANG ⁵ ; Ling XI ⁶ ; Lishu XU ⁷ ; Fen WANG ⁸ ; Hongyi LI ⁹ ; Shu LI ¹⁰ ; Yijun ZHANG ¹¹ ; Shiyun TAN ¹² ; Rutao HONG ¹³ ; Nonghua LYU ¹⁴ ; Mei YE ¹⁵ ; Huatian GAN ¹⁶ ; Miao LIU ¹ ; Benyan WU ¹
Author Information

1. Department of Gastroenterology, The Second Medical Center of PLA General Hospital, Beijing 100853, China
2. Department of Gastroenterology, Beijing Hospital, Beijing 100730, China
3. Department of Gastroenterology, The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China
4. Department of Geriatric Gastroenterology, Shaanxi Provincal People′s Hospital, Xi′an 710068, China
5. Department of Gastroenterology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China
6. Department of Geriatrics, The First Hospital of Shanxi Medical University, Taiyuan 030001, China
7. Department of Geriatrics, Guangdong Provincal People′s Hospital, Guangzhou 510080, China
8. Department of Gastroenterology, The Third Xiangya Hospital of Central South University, Changsha 410013, China
9. Department of Geriatrics, The Seventh Medical Center of PLA General Hospital, Beijing 100700, China
10. Department of Gastroenterology, Tianjin Medical University General Hospital, Tianjin 300052, China
11. Department of Geriatric Gastroenterology, PLA Southern Theater General Hospital, Guangzhou 510010, China
12. Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430060, China
13. Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China
14. Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang 330006, China
15. Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan 430071, China
16. Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, China
Publication Type:Journal Article
Keywords: Dyspepsia; Aged; Postprandial discomfort syndrome; Oryz-Aspergillus enzyme and pancreatin tablet; Mosapride
From: Chinese Journal of Internal Medicine 2020;59(2):117-123
CountryChina
Language:Chinese
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.