Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life

Phase 4

Completed

• Conditions: Minimal Hepatic Encephalopathy; Hepatic Encephalopathy

• Registration Number: NCT00375375
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

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.

Detailed Description

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.)

Study Timeline

• Study Start: 2004-01
• Study Completion: 2004-12
• Study First Submitted: 2006-09-12
• Study First Submitted QC: 2006-09-12
• Study First Posted: 2006-09-13
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-01
• Last Update Posted: 2007-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• All the patients diagnosed as having cirrhosis of liver

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement in minimal hepatic encephalopathy and health related quality of life

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, UT, India