Lactitol in treatment of subclinical hepatic encephalopathy: a double-blind placebo-controlled randomised trial
- Author:
Houyu LIU
1
;
Hong SHI
;
Zhijun FU
;
Liang ZHU
;
Weizhong CHEN
Author Information
1. 上海医科大学附属中山医院
- From:
Chinese Medical Journal
1998;111(2):0-0
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of lactitolin the treatment of subclinical hepatic encephalopathy.Methods From September 19, 1995 to April 25, 1996, 31cases of cirrhotic patients with subclinical hepaticencephalopathy were divided into two groups. Sixteen casesreceived an average of 1.05 ml/day (range from 0.55-1.75ml/kg/day) of 40% lactitol solution orally three times a day toachieve one to two semiformed stools/day for two weeks. Fifteencases were given placebo (5%GW) 10 ml orally three times a dayas control also for 2-week period. The drug and the placebowere the same in colour, package, and taste. The patients'subjective response to treatment and any adverse eventoccurring were recorded before and after two-week's treatment.Assessment of response included two psy-chometric tests[number connection test (NCT) and digitsymbol test (DS)],somatosensory evoked potentialsDepartment of Digestion,(SSEP), blood ammonia and the clinical evaluation of mentalstatus.Results Two of 15 patients in control group had notundergone the reassessment due to overt hepatic encephalopathy,one in stage 3, and the other in stage 4. The remaining 13patients completed the study. In 16 patients completed withlactitol treatment, none showed the evidence of overt hepaticencephalopathy. After a two-week treatment, the blood ammonia,latency of N2, P2, N3, P3 and inter-peak latency of N1-P2,N1-N3 of SSEP were significantly decreased and the NCT, DS weremarkedly improved (P<0.01). The differences found in thecontrol group were not statistically significant. Adverseeffects of lactitol such as flatulence, nausea, diarrhea, andvomiting were mild and transient, and did not affect thetreatment.Conclusion It is suggested that lactitol is a safe andeffective drug for the treatment of subclinical hepaticencephalopathy, and the optimal dose and regimen should beindividually prescribed. It's efficacy in long-term treatmentneeds to be investigated further.
