An efficacy and safety study of bifidobacterium tetragenous viable bacteria tablets in the treatment of constipation in patients with type 2 diabetes mellitus
10.3760/cma.j.issn.0578-1426.2018.04.005
- VernacularTitle:双歧杆菌四联活菌片治疗2型糖尿病患者便秘的有效性及安全性
- Author:
Tao YUAN
1
;
Weigang ZHAO
;
Yong CAO
;
Qi LI
;
Minxiu YAO
;
Xiuxian HAO
;
Hui YU
;
Caie JIANG
;
Haifang WANG
;
Shuping WANG
;
Xiaobo WEI
;
Wei QIU
Author Information
1. 100730,中国医学科学院北京协和医学院北京协和医院内分泌科国家卫生和计划生育委员会内分泌重点实验室
- Keywords:
Constipation;
Diabetes mellitus;
Bifidobacterium tetragenous viable bacteria tablets
- From:
Chinese Journal of Internal Medicine
2018;57(4):252-257
- CountryChina
- Language:Chinese
-
Abstract:
Objective The incidence of gastrointestinal symptoms in diabetes is higher than that of non-diabetes.Thus,the aim of the present study was to observe the efficacy and safety of bifidobacterium tetragenous viable bacteria tablets in the treatment of constipation in patients with type 2 diabetes mellitus.Methods This is a multicenter,randomized,double-blind,placebo-controlled,parallel group-comparison clinical research.The subjects were randomly divided into study group and control group according to 1 ∶ 1 ratio by computer generated random number method.The subjects were either treated with bifidobacterium tetragenous viable bacteria tablets (study group) or placebo (control group) for eight weeks,and they were followed up for four weeks without changing foundation therapy for diabetes.The primary outcome was the change of complete spontaneous bowel movements (CSBMs).Results A total of 234 subjects (the study group:116 cases;the control group:118 cases) from 7 centers were included in the present study.The baseline characteristics were comparable between the two groups.In the study group,the CSBMs at 0,2,4,8 and 12 weeks were 0.0(0.0,1.0),1.0(0.5,2.0),2.0(1.0,3.0),3.0(2.0,3.5),2.0(1.0,3.0) times per week,respectively,while the CSBMs of the control group at each corresponding weeks were 0.0(0.0,1.0),1.0(0.0,1.5),1.0(0.0,1.5),1.0(0.0,2.0),1.0(0.0,1.5)times per week,respectively.There is significant difference in CSBMs between the two groups (P＜0.05).Moreover,after 12 weeks treatment,the CSBMs over spontaneous bowel movements (SBMs) ratio in the study group was higher than that in the control group [0.53 (0.40,0.67) vs 0.33 (0.00,0.50),P=0.048],indicating a more complete evacuation sensation in the study group.More subjects in the study group (66.38％) reached Bristol stool classification of normal criteria than those in the control group (48.31％,P=0.005).There were significantly improvement of bowel function index in the study group [study group 42.7 (33.3,56.7),control group 60.6 (51.7,75.7),P＜0.000 1].Furthermore,the symptoms of constipation was improved,and the satisfaction for the treatment was high in the study group.There were no significant differences of the safety indicators between the two groups.Conclusions Bifidobacterium tetragenous viable bacteria tablets can be used in patients with type 2 diabetes mellitus and constipation.Compared with placebo,it improves constipation and has no obvious adverse effects.
