Clinical trial NCT00375375: Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Minimal Hepatic Encephalopathy
Hepatic Encephalopathy
Keywords: Minimal hepatic encephalopathy
Hepatic encephalopathy
Subclinical hepatic encephalopathy
Health related quality of life
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2006-09-13
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.)

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in minimal hepatic encephalopathy and health related quality of life
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
state: UT
Study officials:
affiliation: Postgraduate Institute of Medical Education and Research, Chandigarh-160012, India
name: Radha K Dhiman, MD,DM, FACG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prasad S, Dhiman RK, Duseja A, Chawla YK, Sharma A, Agarwal R. Lactulose improves cognitive functions and health-related quality of life in patients with cirrhosis who have minimal hepatic encephalopathy. Hepatology. 2007 Mar;45(3):549-59. doi: 10.1002/hep.21533.