title: [Efficacies of lactulose plus live combined Bacillus subtilis and Enterococcus faecium capsules in the treatment of functional constipation: a multicenter, randomized, double blind, controlled trial].
abstract: OBJECTIVE
  To explore the efficacies of live combined Bacillus subtilis (B. subtilis) and Enterococcus faecium (E. faecium) capsules plus lactulose in the treatment of functional constipation.
  
  
  METHODS
  A total of 216 patients fulfilling the diagnostic criteria of functional constipation (slow transit pattern) were randomly enrolled from 9 participating hospitals and allocated into treatment group and control group. The patients of treatment group received lactulose plus live combined B. subtilis and E. faecium capsules for 14 days and only took the latter during the following 14 days. The patients of control group received lactulose plus placebo for 2 weeks and then only took placebo continually for the following 2 weeks.
  
  
  RESULTS
  A total of 216 patients were analyzed (treatment group n = 104, control group n = 112). The effective rates of 7-day treatment were 88.46% (n = 92) and 84.82% (n = 95) for treatment and control groups respectively. And those of 28-day treatment were 87.50% (n = 91) and 81.25% (n = 91)respectively. And the inter-group differences were not statistically significant (all P > 0.05). Fecal form, frequency, difficulty, urgency, distension, abdominal pain and expelling rates of barium enema were not statistically significant (all P > 0.05). Comparing the effective rates of 28-day with that of 14-day, differences were not statistically significant in A group (S = 0.5, P = 0.4795), but in B group the effective rates of 28-day were lower than that of 14-day statistically(S = 11, P = 0.0009).
  
  
  CONCLUSIONS
  The regiment of live combined B. subtilis and E. faecium capsules plus lactulose offers better efficacies in the treatment of functional constipation.
authors: Department of Gastroenterology, General Hospital of Beijing Military Region, Beijing, China. li.shirong@yahoo.cn
authors: Shi-Rong
authors: SR
authors: Li
authors: Hua-Hong
authors: HH
authors: Wang
authors: Zuo-Yan
authors: ZY
authors: Wu
authors: Reng-Hai
authors: RH
authors: Liu
authors: Mu-Hong
authors: MH
authors: Tong
authors: Cang-Hai
authors: CH
authors: Wang
authors: Rui-Ling
authors: RL
authors: Wang
authors: Hong-Chuan
authors: HC
authors: Zhao
authors: Wei
authors: W
authors: Wei
mesh_terms: D000328:Adult; D001412:Bacillus subtilis; D003248:Constipation / Q000628:therapy*; D004311:Double-Blind Method; D016984:Enterococcus faecium; D005260:Female; D006801:Humans; D007792:Lactulose / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000627:therapeutic use*
chemical_list: D007792:Lactulose