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

This study has been completed.
Information provided by:
Postgraduate Institute of Medical Education and Research Identifier:
First received: September 12, 2006
Last updated: March 1, 2007
Last verified: March 2007

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.

Condition Intervention Phase
Minimal Hepatic Encephalopathy
Hepatic Encephalopathy
Drug: Lactulose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Improvement in minimal hepatic encephalopathy and health related quality of life

Estimated Enrollment: 80
Study Start Date: January 2004
Estimated Study Completion Date: December 2004
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.)


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00375375

Postgraduate Institute of Medical Education and Research
Chandigarh, UT, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Principal Investigator: Radha K Dhiman, MD,DM, FACG Postgraduate Institute of Medical Education and Research, Chandigarh-160012, India
  More Information

Publications: Identifier: NCT00375375     History of Changes
Other Study ID Numbers: Minimal hepatic encephalopathy
Study First Received: September 12, 2006
Last Updated: March 1, 2007

Keywords provided by Postgraduate Institute of Medical Education and Research:
Minimal hepatic encephalopathy
Hepatic encephalopathy
Subclinical hepatic encephalopathy
Health related quality of life

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Brain Diseases, Metabolic
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Metabolic Diseases
Gastrointestinal Agents processed this record on May 22, 2017