Lactulose is highly potential in prophylaxis of hepatic encephalopathy in patients with cirrhosis and upper gastrointestinal bleeding: results of a controlled randomized trial.

BACKGROUND AND AIMS: Upper gastrointestinal bleeding (UGB) is an important precipitating factor for the development of hepatic encephalopathy (HE) in cirrhotic patients. The aim of this study was to evaluate the efficacy of lactulose in a controlled randomized trial for prophylaxis of HE after UGB. PATIENTS AND METHODS: 128 cirrhotic patients with UGB were consecutively classified according to Child-Pugh criteria and randomized to receive lactulose (group A, n = 63) or no lactulose (group B, n = 65) treatment after the symptoms of active bleeding disappeared. Curative effects were observed for 6 days. RESULTS: Two patients in group A and 11 in group B had developed HE; the incidence rates were 3.2 and 16.9% (χ(2) 5.2061, p < 0.05). After treatment, a significant increase in ammonia level and higher number connection test (NCT) in the non-lactulose group, median blood ammonia levels (60.0 vs. 52.0), p < 0.05, and median NCT (43 vs. 38), p < 0.05, were observed. Patients who had developed HE had a significantly higher baseline Child-Turcotte-Pugh score (10.15 ±1.82 vs. 6.35 ± 1.60, p < 0.05), alanine aminotransferase (111.25 ± 91.62 vs. 48.32 ± 47.45, p < 0.05), aspartate aminotransferase (171.42 ± 142.68 vs. 46.33 ± 42.68, p < 0.05), total bilirubin (73.44 ± 47.20 vs. 29.75 ± 22.08, p < 0.05), serum albumin (24.65 ± 5.04 vs. 33.43 ± 6.49, p < 0.05), plasma prothrombin time (22.18 ± 4.60 vs. 17.12 ± 4.62, p < 0.05), and lower hemoglobin level (72.31 ± 15.15 vs. 87.45 ± 19.79, p < 0.05) as compared to patients who did not develop HE. On unconditional logistic regression analysis, patients who had developed HE were significantly associated with a higher baseline Child-Turcotte-Pugh score (OR 9.92, 95% CI 1.94-50.63, p < 0.05) and lactulose therapy (OR 0.02, 95% CI 0-0.74, p < 0.05) but were not associated with other parameters. CONCLUSIONS: Lactulose is an effective prophylaxis agent of HE for cirrhotic patients who had developed UGB.

[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].

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). CONCLUSION: The regiment of live combined B. subtilis and E. faecium capsules plus lactulose offers better efficacies in the treatment of functional constipation.