[An efficacy and safety study of bifidobacterium tetragenous viable bacteria tablets in the treatment of constipation in patients with type 2 diabetes mellitus].

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.

Study of the prevalence of diabetes mellitus in adults in the Shougang Corporation in Beijing.

The aim was to determine the burden of diabetes mellitus (DM) in an urban area of China to aid us in planning preventive measures for those at risk of DM. A survey was conducted among the 29,859 subjects aged between 30 and 64 belonging to 32 units of the Shougang Corporation (a heavy industry enterprise) within the Beijing area. WHO study protocols and diagnostic criteria were used to determine the prevalence of DM and impaired glucose tolerance (IGT). The results showed that the age-adjusted prevalence of DM and impaired glucose tolerance (IGT) was 3.63% and 4.19%, respectively, both increasing with age. Peak prevalence for both occurred in the 60-64 age group. Prevalence showed no difference between the sexes in DM but was higher for females in IGT. Obesity, being overweight, a family history of diabetes mellitus and in women, a history of delivering babies with macrosomia, all correlated closely with the prevalence of DM and IGT. High protein intake was also associated with DM, Smoking had no effect on either DM or IGT. Intellectual workers had a higher incidence of IGT than manual workers. Seventy per cent DM was undiagnosed prior to the survey. This survey, done according to the recommendation of WHO, and including appropriate adjustments, reflects the growing prevalence of DM and IGT in this population. It can be compared with other studies for epidemiological analysis.