Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Improvement in minimal hepatic encephalopathy and health related quality of life
研究概览
简要总结
Minimal hepatic encephalopathy (MHE) has a negative effect on patients' daily functioning. No study has so far investigated the effect of treatment related improvement in cognitive functions on health related quality-of-life (HRQOL). This study was carried out to determine the influence of treatment on psychomotor performance and on HRQOL in patients with MHE.
The mean number of abnormal NP tests decreased significantly in patients in treated group compared with patients in untreated group MANOVA for time and treatment, P =.001). Mean total SIP score improved among patients in the treated group after 3 months compared with patients in untreated group after 3 months (MANOVA for time and treatment, P=.002). Improvement in HRQOL was related to the improvement in psychometry. In conclusion, treatment with lactulose improves both cognitive functions and HRQOL in cirrhotic patients with MHE.
详细描述
The study has been published in March 2007 in Hepatology
Lactulose Improves Cognitive Functions and Health-Related Quality of Life in Patients with Cirrhosis WhoHave Minimal Hepatic Encephalopathy.Srinivasa Prasad, Radha K. Dhiman, Ajay Duseja, Yogesh K. Chawla, Arpita Sharma, and Ritesh Agarwal. (HEPATOLOGY 2007;45:549-559.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients diagnosed as having cirrhosis of liver
排除标准
- •Overt HE or a history of overt HE;
- •History of recent (< 6 weeks) alcohol intake;
- •Infection, recent (< 6 weeks) antibiotic use or gastrointestinal bleeding;
- •History of recent (< 6 weeks) use of drugs affecting psychometric
- •Performances like benzodiazepens, antiepileptics, psychotropic drugs;
- •History of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension;
- •Electrolyte imbalance;
- •Renal impairment;
- •Presence of hepatocellular carcinoma;
- •Severe medical problems such as congestive heart failure, pulmonary disease, neurological or psychiatric disorder, etc., that could influence quality-of-life measurement;
- •Inability to perform NP tests and to complete the SIP questionnaire due to bad vision.
结局指标
主要结局
Improvement in minimal hepatic encephalopathy and health related quality of life
次要结局
未报告次要终点