title: Efficacy of Nutritional Therapy for Patients With Cirrhosis and Minimal Hepatic Encephalopathy in a Randomized Trial.
abstract: OBJECTIVE
  Minimal hepatic encephalopathy (MHE) impairs health-related quality of life (HRQOL), leads to the development of overt HE, and is associated with poor outcome. We performed a randomized controlled trial to assess the effects of nutritional therapy on cognitive functions and HRQOL in patients with cirrhosis with MHE.
  
  
  METHODS
  In a tertiary care setting in New Delhi, India, patients with cirrhosis with MHE were assigned randomly to groups given nutritional therapy (30-35 kcal/kg/d, 1.0-1.5 g vegetable protein/kg/d; n = 60; age, 42.1 ± 10.3 y; 48 men) or no nutritional therapy (patients continued on their same diet; n = 60; age, 42.4 ± 9.6 y; 47 men) for 6 months in 2014. MHE was diagnosed based on their psychometry hepatic encephalopathy score (PHES). HRQOL was assessed by a sickness impact profile (SIP) questionnaire. Primary end points were improvement or worsening in MHE and improvement in HRQOL.
  
  
  RESULTS
  There was no significant difference in baseline PHES (-8.12 ± 1.32 vs -8.53 ± 1.38; P = .08) or SIP (14.25 ± 5.8 vs 15.44 ± 5.03; P = .85) scores. After the 6-month study period, a higher proportion of patients in the nutritional therapy group had reversal of MHE (71.1% vs 22.8%; P = .001). Patients in the nutritional therapy group also had larger increases in PHES (3.86 ± 3.58 vs 0.52 ± 4.09; P = .001) and HRQOL (improvement in SIP score of 3.24 ± 3.63 vs 0.54 ± 3.58; P = .001). Overt HE developed in 10% of patients in the nutritional therapy group vs 21.7% of the control group (P = .04).
  
  
  CONCLUSIONS
  Based on a randomized controlled trial performed in India, nutritional therapy is effective in the treatment of MHE and is associated with improvement in HRQOL. Clinical Trial Registry-India registration no: CTRI/2013/07/003851.
authors.affiliation: Department of Gastroenterology, G.B. Pant Hospital, New Delhi, India.
authors.forename: Sudhir
authors.initials: S
authors.lastname: Maharshi
authors.affiliation: Department of Gastroenterology, G.B. Pant Hospital, New Delhi, India. Electronic address: drbcsharma@hotmail.com.
authors.forename: Barjesh Chander
authors.initials: BC
authors.lastname: Sharma
authors.affiliation: Department of Gastroenterology, G.B. Pant Hospital, New Delhi, India.
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Sachdeva
authors.affiliation: Department of Gastroenterology, G.B. Pant Hospital, New Delhi, India.
authors.forename: Siddharth
authors.initials: S
authors.lastname: Srivastava
authors.affiliation: Department of Gastroenterology, G.B. Pant Hospital, New Delhi, India.
authors.forename: Praveen
authors.initials: P
authors.lastname: Sharma
mesh_terms: D000328:Adult; D004035:Diet Therapy / Q000379:methods*; D005260:Female; D006501:Hepatic Encephalopathy / Q000473:pathology / Q000628:therapy*; D006801:Humans; D007194:India; D008103:Liver Cirrhosis / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D062606:Tertiary Care Centers; D016896:Treatment Outcome
keywords: Liver Disease; Nutrient; Psychiatric; Variceal Bleeding