{"title":"乳果糖与番泻叶加ispagaula壳对透析前慢性肾病和便秘患者的疗效:一项随机对照试验。","authors":"Naowanit Nata, Supaporn Suebsiripong, Bancha Satirapoj, Ouppatham Supasyndh, Amnart Chaiprasert","doi":"10.2147/IJNRD.S328208","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Constipation 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.</p><p><strong>Objective: </strong>The aim of the study was to compare efficacy of lactulose and senna plus ispaghula husk to treat constipation among patients with pre-dialysis CKD.</p><p><strong>Methods: </strong>A 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).</p><p><strong>Results: </strong>A 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.</p><p><strong>Conclusion: </strong>Lactulose and senna plus ispaghula husk were similar in efficacy to treat constipation among patients with pre-dialysis CKD.</p><p><strong>Trial registration: </strong>Thai Clinical Trials number is TCTR20200818006. Retrospectively Registered 18 August 2020.</p>","PeriodicalId":14181,"journal":{"name":"International Journal of Nephrology and Renovascular Disease","volume":"14 ","pages":"313-319"},"PeriodicalIF":2.1000,"publicationDate":"2021-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/40/2a/ijnrd-14-313.PMC8357401.pdf","citationCount":"4","resultStr":"{\"title\":\"Efficacy of Lactulose versus Senna Plus Ispaghula Husk Among Patients with Pre-Dialysis Chronic Kidney Disease and Constipation: A Randomized Controlled Trial.\",\"authors\":\"Naowanit Nata, Supaporn Suebsiripong, Bancha Satirapoj, Ouppatham Supasyndh, Amnart Chaiprasert\",\"doi\":\"10.2147/IJNRD.S328208\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Constipation 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.</p><p><strong>Objective: </strong>The aim of the study was to compare efficacy of lactulose and senna plus ispaghula husk to treat constipation among patients with pre-dialysis CKD.</p><p><strong>Methods: </strong>A 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).</p><p><strong>Results: </strong>A 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.</p><p><strong>Conclusion: </strong>Lactulose and senna plus ispaghula husk were similar in efficacy to treat constipation among patients with pre-dialysis CKD.</p><p><strong>Trial registration: </strong>Thai Clinical Trials number is TCTR20200818006. Retrospectively Registered 18 August 2020.</p>\",\"PeriodicalId\":14181,\"journal\":{\"name\":\"International Journal of Nephrology and Renovascular Disease\",\"volume\":\"14 \",\"pages\":\"313-319\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2021-08-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/40/2a/ijnrd-14-313.PMC8357401.pdf\",\"citationCount\":\"4\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Nephrology and Renovascular Disease\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2147/IJNRD.S328208\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2021/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Nephrology and Renovascular Disease","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/IJNRD.S328208","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
Efficacy of Lactulose versus Senna Plus Ispaghula Husk Among Patients with Pre-Dialysis Chronic Kidney Disease and Constipation: A Randomized Controlled Trial.
Background: Constipation 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.
Objective: The aim of the study was to compare efficacy of lactulose and senna plus ispaghula husk to treat constipation among patients with pre-dialysis CKD.
Methods: A 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).
Results: A 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.
Conclusion: Lactulose and senna plus ispaghula husk were similar in efficacy to treat constipation among patients with pre-dialysis CKD.
Trial registration: Thai Clinical Trials number is TCTR20200818006. Retrospectively Registered 18 August 2020.
期刊介绍：
International Journal of Nephrology and Renovascular Disease is an international, peer-reviewed, open-access journal focusing on the pathophysiology of the kidney and vascular supply. Epidemiology, screening, diagnosis, and treatment interventions are covered as well as basic science, biochemical and immunological studies. In particular, emphasis will be given to: -Chronic kidney disease- Complications of renovascular disease- Imaging techniques- Renal hypertension- Renal cancer- Treatment including pharmacological and transplantation- Dialysis and treatment of complications of dialysis and renal disease- Quality of Life- Patient satisfaction and preference- Health economic evaluations. The journal welcomes submitted papers covering original research, basic science, clinical studies, reviews & evaluations, guidelines, expert opinion and commentary, case reports and extended reports. The main focus of the journal will be to publish research and clinical results in humans but preclinical, animal and in vitro studies will be published where they shed light on disease processes and potential new therapies and interventions.
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