Efficacy and safety of Bifidobacterium tetravaccine tablets in the treatment of persistent and chronic diarrhea: a randomized controlled clinical study / 中华消化杂志

ABSTRACT

Objective To compare the differences in the efficacy of Bifidobacterium tetravaccine tablets.Bifidobacterium triple viable capsules and live Bacillus licheniformis capsule in the treatment of persistent and chronic diarrhea.Methods From September 2015 to June 2016,a total of 484 outpatients with persistent and chronic diarrhea were enrolled and divided into observation group (treated with Bifidobacterium tetravaccine tablets) and control group (treated with the combination of Bifidobacterium triple viable capsules and live Bacillus licheniformis capsule).Before and after treatment,the frequency of defecation and the characters of stool were observed and the differences in the treatment efficacy in persistent and chronic diarrhea between two groups were compared.Paired t test and Chi square test were used to compare the difference before and after treatment in each group,and independent sample t test was used for comparison between groups.Results There were a total of 256 patients in the observation group (four cases lost and 256 cases were completed).Meanwhile there were 228 patients in the control group (30 cases lost and 228 cases completed).In the observation group,after treatment the frequency of defecation was (2.13±1.06) times,which was less than that before treatment ((3.83±0.95) times),and the difference was statistically significant (t=29.149,P＜0.01).In the control group,after treatment the frequency of defecation was (2.19 ± 1.06) times,which was less than that before treatment ((3.87 ±0.98) times),and the difference was statistically significant(t =27.800,P＜0.01).There was no statistically significant difference in the frequency of defecation before and after treatment between two groups (t=-0.460 and-0.662,both P＞0.05).Furthermore there was also no statistically significant difference in the rate of normal bowel movements between observation group and treatment group after treatment (50.8％(130/256) vs 57.9％(132/228;x2=2.458,P=0.117).There was no significant difference in effective rate (64.8％(166/256) vs 69.7％ (159/228) and excellence rate (47.7％ (122/256) vs 51.3％ (117/228)) between two groups (P=0.253 and 0.422);besides,no severe adverse events were reported.Conclusion In the aspect of improving of times of defecation and characters of stool in patients with persistent and chronic diarrhea,single medication of multi bacteria strains Bifidobacterium tetravaccine tablets has the same satisfied efficacy and good safety as the combination of Bifidobacterium triple viable capsules and live Bacillus licheniformis capsule.