Efficacy of Lactulose versus Senna Plus Ispaghula Husk Among Patients with Pre-Dialysis Chronic Kidney Disease and Constipation: A Randomized Controlled Trial.

Abstract

BackgroundConstipation is a common problem among patients with advanced chronic kidney disease (CKD), leading to a loss of quality of life. Pharmacologic treatments are in common use, but whether lactulose and senna plus ispaghula husk is effecive to treat constipation among patients with pre-dialysis CKD remains unknown.ObjectiveThe aim of the study was to compare efficacy of lactulose and senna plus ispaghula husk to treat constipation among patients with pre-dialysis CKD.MethodsA study was conducted among patients with pre-dialysis CKD receiving a diagnosis of constipation by ROME IV criteria. All subjects were randomly assigned to receive either lactulose or senna plus ispaghula husk daily for 14 days. After a 7-day washout period, the patients were switched to the other substance for another 14 days. Primary outcome was complete spontaneous bowel movement (CSBM) weekly, assessed using a stool diary after each laxative. Secondary outcome measure was the change of stool appearance using the Bristol stool form scale (BSFS).ResultsA total of 22 patients underwent randomization. Baseline CSBM and BSFS were 3.4 ± 1.4 and 2.3 ± 1.2 time/week, respectively. At the end of the study, the mean CSBM weekly increased in the lactulose group (mean difference 1.3 ± 1.6, P < 0.001) and the senna plus ispaghula husk group (mean difference 2.1 ± 2.1, P < 0.001) from baseline. Comparing CSBM between lactulose and senna plus ispaghula husk exhibited no significant difference (95% CI −1.2 to 0.06; P = 0.276). BSFS was significantly changed after using ispaghula husk with senna, the mean ± SD of BSFS changed to 1.7 ± 1.8 (p = 0.001) and after use lactulose, the mean ± SD of BSFS changed to 1.6 ± 1.8 (p = 0.001). No significant BSFS change was observed between groups regarding stool appearance. No serious adverse event in either group was found.ConclusionLactulose and senna plus ispaghula husk were similar in efficacy to treat constipation among patients with pre-dialysis CKD.Trial RegistrationThai Clinical Trials number is TCTR20200818006. Retrospectively Registered 18 August 2020.