Clinical Observation of Lactulose Combined with Bacillus subtilis Bifarous Viable Bacteria in the Treatment of Functional Constipation / 中国药房

ABSTRACT

OBJECTIVE:To observe the clinical efficacy and safety of lactulose combined with Bacillus subtilis bifarous via-ble bacteria in the treatment of functional constipation(FC). METHODS:In a randomized double blind controlled study,60 FC pa-tients were randomly assigned into treatment group(28 cases)and control group(32 cases). Both groups received lactulose orally. Treatment group additionally receive B. subtilis bifarous viable bacteria,and control group additionally received placebo continually. 2 weeks later,both groups stopped taking lactulose but continued to take adjunctive drug till 4th week. The defecate frequencies, stool property,constipation symptoms,quality of life and ADR were compared between 2 groups before treatrnent and 2nd,4th week cofter treatment. RESULTS:In the second week ,the defecate frequencies,stool property and constipation symptoms of both groups were significantly improved,with statistical significance (P<0.05). Compared with the control group in the fourth week, these constipation symptoms of treatment group were improved more significantly,with statistical significance (P<0.05). In the fourth week,aspects of quality of life in both groups were significantly improved,with statistical significance(P<0.05);physical discomfort scores,satisfaction scores and total scores of treatment group were improved significantly,compared with the control group,there was statistical significance (P<0.05). There were no severe ADR in both groups. CONCLUSIONS:Lactulose com-bined with B. subtilis bifarous viable bacteria can effectively relieve FC,improve abdominal symptoms and slow the recurrence of constipation,which is safe and reliable.