Ya-Ping Liu1, Xin Liu, Lei Dong. 1. Department of Gastroenterology, Second Affiliated Hospital, College of Medicine, Xi'an Jiaotong University, Xi'an, China.
Abstract
OBJECTIVE: To explore the therapeutic efficacy and safety of lactulose plus live binary Bacillus subtilis in elders with functional constipation. METHODS: A total of 97 elder outpatients or inpatients with functional constipation at our department from September 2011 to April 2012 were divided into 3 groups: lactulose treatment (n = 32), live binary Bacillus subtilis treatment (n = 31) and combined treatment (n = 34). Among them, there were 57 males and 40 females with an average age of (74 ± 6) years old. The course of treatment was 4 weeks in all groups. Then we observed the effective time, therapeutic efficacy, adverse reaction and change of life quality. RESULTS: (1) There were 62.5% (20/32) effective patients in the lactulose treatment group, 41.9% (13/31) in live binary Bacillus subtilis treatment group and 82.4% (28/34) in combined treatment group during 48 hours. Combined treatment group was significantly higher than lactulose treatment group (P < 0.05) and live binary Bacillus subtilis treatment group (P < 0.01). And lactulose treatment group was higher than live binary Bacillus subtilis treatment group (P < 0.05). (2) After 4 weeks, the total effective rates were 68.7% (22/32), 41.9% (13/31)and 94.2% (32/34)respectively. Combined treatment group was significantly higher than lactulose treatment group (P < 0.05) and live binary Bacillus subtilis treatment group (P < 0.01). Meanwhile, lactulose treatment group was superior to live binary Bacillus subtilis treatment group (P < 0.05). (3) After 4 weeks, there was no statistic difference in total adverse reaction rates among 3 groups (P > 0.05). (4) The life quality score of combined treatment group was significantly higher than lactulose treatment group (P < 0.05) and live binary Bacillus subtilis treatment group (P < 0.01) and lactulose treatment group was higher than live binary Bacillus subtilis treatment group (P < 0.05) after a 4-week treatment. CONCLUSIONS: The combined regimen of lactulose and live binary Bacillus subtilis is more effective than lactulose or live binary Bacillus subtilis alone. Besides, there is no significant increase in adverse reactions. Thus the combined regimen of lactulose and live binary Bacillus subtilis is an effective and safe therapeutic method for elders with functional constipation.
RCT Entities:
OBJECTIVE: To explore the therapeutic efficacy and safety of lactulose plus live binary Bacillus subtilis in elders with functional constipation. METHODS: A total of 97 elder outpatients or inpatients with functional constipation at our department from September 2011 to April 2012 were divided into 3 groups: lactulose treatment (n = 32), live binary Bacillus subtilis treatment (n = 31) and combined treatment (n = 34). Among them, there were 57 males and 40 females with an average age of (74 ± 6) years old. The course of treatment was 4 weeks in all groups. Then we observed the effective time, therapeutic efficacy, adverse reaction and change of life quality. RESULTS: (1) There were 62.5% (20/32) effective patients in the lactulose treatment group, 41.9% (13/31) in live binary Bacillus subtilis treatment group and 82.4% (28/34) in combined treatment group during 48 hours. Combined treatment group was significantly higher than lactulose treatment group (P < 0.05) and live binary Bacillus subtilis treatment group (P < 0.01). And lactulose treatment group was higher than live binary Bacillus subtilis treatment group (P < 0.05). (2) After 4 weeks, the total effective rates were 68.7% (22/32), 41.9% (13/31)and 94.2% (32/34)respectively. Combined treatment group was significantly higher than lactulose treatment group (P < 0.05) and live binary Bacillus subtilis treatment group (P < 0.01). Meanwhile, lactulose treatment group was superior to live binary Bacillus subtilis treatment group (P < 0.05). (3) After 4 weeks, there was no statistic difference in total adverse reaction rates among 3 groups (P > 0.05). (4) The life quality score of combined treatment group was significantly higher than lactulose treatment group (P < 0.05) and live binary Bacillus subtilis treatment group (P < 0.01) and lactulose treatment group was higher than live binary Bacillus subtilis treatment group (P < 0.05) after a 4-week treatment. CONCLUSIONS: The combined regimen of lactulose and live binary Bacillus subtilis is more effective than lactulose or live binary Bacillus subtilis alone. Besides, there is no significant increase in adverse reactions. Thus the combined regimen of lactulose and live binary Bacillus subtilis is an effective and safe therapeutic method for elders with functional constipation.