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 1â¶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.
Subject(s)
Bifidobacterium , Constipation/therapy , Diabetes Mellitus, Type 2/complications , Tablets/administration & dosage , Constipation/complications , Double-Blind Method , Feces , Humans , Treatment OutcomeABSTRACT
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.
ABSTRACT
Objective To explore the efficacy and safety of bifidobacterium tetragenous viable bacteria tablets (BTVBT) in blood glucose control in patients with type 2 diabetes mellitus (T2DM).Methods This study was a randomized, double-blind, placebo parallel comparison, multicentre clinical research.The subjects were T2DM patients who were using anti-hyperglycemic drugs.They were randomly divided into observation group and control group according to 1∶1 ratio.The subjects accepted the therapy of BTVBT or placebo by oral administration (3 tablets, tid) for eight weeks, followed up for 4 weeks, during which the basic treatment maintained unchanged.The primary outcomes: the changes of glycosylate hemoglobin A1c (HbA1c) from baseline.Results Totally 234 subjects (116 cases in observation group and 118 cases in control group) from 7 centers were included in the study.The baseline characteristics were comparable between these two groups.The HbA1c was (8.00±1.08)％ and (7.99±1.03)％ in observation group and control group, respectively, at baseline, and was (7.28±1.28)％ and (7.36±1.02)％ after 12 weeks of treatment [(-0.66±1.38)％ vs.(-0.64±1.14)％,P=0.914 5].The secondary outcomes were as follows: the fasting blood glucose (FBG) in the observation group were (7.91±1.87)mmol/L and (8.05±2.33)mmol/L at baseline and after 12 weeks of treatment;while in the control group, the FBG were (8.51±1.68)mmol/L and (8.00±2.02)mmol/L, and comparisons between two groups showed no significant change (P>0.05).The glycated albumin in the observation group and control group were (21.38±5.74)％ and (21.93±6.51)％ at baseline;after 4 weeks of treatment, they were (20.08±6.05)％ and (20.58±7.30)％ (the changes from baseline in these two groups were (-1.19±4.37)％ and (-1.20±5.08)％];after 8 weeks of treatment, they were (19.07±5.56)％ and (20.83±8.74)％ [the changes from baseline were (-2.09±4.51)％ and (-0.98±6.85)％];after 12 weeks of treatment, they were (19.03±5.19)％ and (19.36±6.14)％ [the changes from baseline were (-2.18±4.60)％ and (-2.47±5.20)％], there were no significant differences between two groups (P>0.05).The subgroup analysis showed that in those patients with the characteristics including body mass index (BMI)≥25 kg/m2 at baseline, the duration of diabetes mellitus longer than 8 years, fasting blood glucose less than 8 mmol/L and using insulin at baseline, the changes of HbA1c from baseline to the end of 12 weeks therapy in the observation group were more than in the control group.There were no significant differences between the two groups in terms of safety profiles, including the vital signs and laboratory findings (blood cell counts, liver function, and kidney function, all P>0.05).Conclusion Administration of BTVBT in T2DM patients for 12 weeks does not remarkably improve the HbA1c.
