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

Study Overview
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Brief Summary
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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
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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.)

Conditions
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Hepatic Encephalopathy, Minimal Hepatic Encephalopathy

Intervention / Treatment
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* Drug: Lactulose


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lactulose|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in minimal hepatic encephalopathy and health related quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimal hepatic encephalopathy, Hepatic encephalopathy, Subclinical hepatic encephalopathy, Health related quality of life