Comparative effectiveness of lactulose and sennosides for the prevention of peritoneal dialysis-related peritonitis: an open-label, randomized, active-controlled trial.

BACKGROUND: To the best of our knowledge, the effectiveness and safety of lactulose in comparison to sennosides, for the prevention of peritoneal dialysis (PD)-related peritonitis, has never been tested in a randomized study. METHODS: We conducted an open-label, randomized, active-controlled trial in a PD-center in Northern Thailand. Adult patients on PD were enrolled and randomly assigned in a 1:1 ratio into two groups; one group received lactulose 15 mL once daily (n = 50) and the other group received sennosides two tablets daily (n = 50). The primary outcome was time-to-first bacterial peritonitis. The secondary outcomes included a composite of bacterial peritonitis and all-cause mortality. Cox proportional hazards regression was calculated and presented as hazard ratios (HRs) with 95% confidence intervals (CIs). RESULTS: One hundred PD patients were recruited (50.0% men; mean age 55.5 ± 13.0 years) in this study. The baseline characteristics of the study participants were similar in both groups. No significant trend towards a higher risk of PD-related peritonitis was observed in the lactulose group (HR, 2.32 [95% CI, 0.92-5.83]; p = .051) compared to the sennosides group. Nevertheless, the secondary outcome was significantly higher in the lactulose group (HR, 2.77 [95% CI, 1.20-6.41]; p = .010). The incidence of adverse events was not substantially different between the two groups; however, diarrhoea was more frequent in the lactulose group (38.0% vs. 18.0%; p = .030) than in the sennosides group. CONCLUSIONS: Treatment with lactulose is not more effective than sennosides and cannot be routinely recommended for the prevention of peritonitis among the PD population. TRIAL REGISTRATION Thai Clinical Trial Registry (clinicaltrials.in.th); ID: TCTR20171012001 KEY MESSAGE To the best of our knowledge, no randomized controlled trial that compares the efficacy and safety profiles of lactulose versus sennosides for the prevention of PD-related peritonitis among the PD population has been conducted. In this open-label, randomized, active-controlled trial, treatment with lactulose is not more effective than sennosides in the prevention of PD-related peritonitis, and it could increase the risk of bacterial PD-related peritonitis. Further studies with a larger sample size by incorporated real-world evidence are needed to confirm our findings and to explore strategies to prevent peritonitis among PD patients.

Polyethylene glycol versus split high-dose senna for bowel preparation: A comparative prospective randomized study.

BACKGROUND AND AIM: The aim of this study was to compare the quality and tolerability of bowel preparation using split high-doses of sennosides versus split-dose polyethylene glycol (PEG). METHODS: In this prospective, randomized, and endoscopist-blinded study, 474 outpatients were included and randomly assigned to two groups: Group 1 was comprised of 237 patients receiving split high-dose (1000 mg) sennoside solutions, and group 2 included 237 patients receiving 4 L of PEG. The efficacy of the preparations was evaluated on the Boston Bowel Preparation Scale (BBPS), and compliance and adverse effects were recorded. RESULTS: The quality of colon cleansing and the ease of bowel preparation were significantly better in the senna group; the mean of total BBPS scores was 7.35 in the senna group and 6.57 in the PEG group, cleansing was adequate (BBPS score ≥ 6) in 89.9% of patients taking senna, and 73.8% in the PEG group (P = 0.001). The rates of vomiting in the senna and PEG groups were 12.7% and 29.5%, nausea rates were 28.7% and 43.9%, and abdominal pain rates were 70.9% and 43%, respectively (P < 0.001). Cecal intubation rates in the senna and PEG groups were 95.4% and 86.1% (P = 0.001), and the cecal intubation times were 6.73 ± 2.84 and 5.34 ± 5.98 min, respectively (P = 0.001). CONCLUSIONS: Split high-dose senna is more effective than split-dose PEG in terms of bowel preparation quality and patient compliance. The patients who received senna had significantly less vomiting and nausea but significantly more abdominal pain. Thus, senna may be used as an alternative to PEG for bowel preparation.

The hospital-based evaluation of laxative prophylaxis in ICU (HELP-ICU): A pilot cluster-crossover randomized clinical trial.

PURPOSE: Prophylactic laxative regimens may prevent constipation but may increase diarrhea and subsequent rectal tube insertion. Our aim was to compare three prophylactic laxative regimens on the rate of rectal tube insertion (primary outcome) and major constipation- or diarrhea-associated complications. MATERIAL AND METHODS: We conducted a cluster-crossover trial. Three pods in a single ICU were each randomized to one of three regimens for four months with rolling cross-over. All mechanically-ventilated and enterally-fed adult patients received either regimen: A) one coloxyl with senna BD from day one; B) two coloxyl with senna +20 ml lactulose BD commencing on day 3; or C) two coloxyl with senna tablets +20 ml lactulose BD commencing on day 6. RESULTS: We enrolled 570 patients (A = 170, B = 205, C = 195) with similar baseline features. Overall, 53 (9.3%) patients received a rectal tube, and insertion rate was not statistically different between the three regimens (A = 12.9%, B = 7.8%, C = 7.7%; p = 0.15). The proportions of patients with other major constipation- or diarrhea-associated complications were similar, as were major patient-centred outcomes. CONCLUSION: Earlier commencement of a prophylactic coloxyl-based laxative regimen (day 1 or 3) did not affect the rates of complications associated with constipation or diarrhea when compared to delayed introduction (day 6).