Hepatitis B - I'm a 45 y/o male with a dual diagnosis of end stage liver disease due to HepB and?

Please read this. I am printing this out so others may read it.

After reading this, then it will explain why, always get to know your drugs the doctor gives you.

Is Lactulose Effective Therapy for Hepatic Encephalopathy?
Contrary to popular belief, lactulose and lactitol have no significant benefit for patients with hepatic encephalopathy.

Hepatic encephalopathy is a neuropsychiatric syndrome that often complicates acute or chronic advanced liver disease. Manifestations range from subclinical neuropsychiatric changes to focal neurologic signs or frank coma. Traditionally, treatment involves antibiotics to reduce ammonia-producing colonic bacteria and lactulose to acidify the colonic lumen, to reduce ammonia absorption, and to improve stool clearance.

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When lactulose was first introduced, results from placebo-controlled trials showed no benefit, but it became the standard of care as studies indicated that it was as efficacious as neomycin, but associated with fewer side effects. Since that time, few studies have compared lactulose with either placebo or antibiotic therapy. In this systematic review, Danish researchers identified randomized trials that compared nonabsorbable disaccharides (lactulose and lactitol) with no treatment, placebo, or antibiotics. Data from 22 (of 444) references were included in the analysis; most studies were excluded because of poor quality or design.

In 10 trials (280 patients), lactulose or lactitol was compared with placebo or no treatment (median treatment duration, 15 days). Only six trials adjusted the lactulose dose to obtain a desired stool frequency. Compared with placebo or with no treatment, neither lactulose nor lactitol significantly reduced the risk for no improvement of hepatic encephalopathy (relative risk, 0.62) or the risk for mortality. Analysis of data from two "high-quality" trials revealed no significant effect of the disaccharides, whereas analysis of data from four "low-quality" trials revealed significant benefit from disaccharides (however, the difference in treatment effect was not significant). Among patients with minimal hepatic encephalopathy (all low-quality studies), lactulose or lactitol significantly reduced the risk for no improvement. The authors were unable to perform a reliable meta-analysis of safety data.

In 12 trials (698 patients), nonabsorbable disaccharides were compared with antibiotics (neomycin, ribostamycin, vancomycin, or rifaximin) for a median treatment duration of 15 days. Compared with antibiotics, disaccharides were associated with significantly higher risk for no improvement, with higher blood ammonia levels, and with similar mortality risk.

Comment: In contrast with typical dogma and (I must admit) my own clinical practice, these results indicate that lactulose and lactitol have no significant benefit for patients with hepatic encephalopathy. In fact, the disaccharides fared worse than antibiotics. Unfortunately, as the authors point out, we have fallen into several pitfalls: Many of us are treating patients with something that has minimal or no documented efficacy, but because of ethical concerns, further placebo-controlled trials of new agents for encephalopathy are unlikely. In addition, any trials that are performed likely will use lactulose, perhaps inappropriately, as the standard of care.

— Kenneth D. Flora, MD

Published in Journal Watch Gastroenterology June 29, 2004

Citation(s):
Als-Nielsen B et al. Non-absorbable disaccharides for hepatic encephalopathy: Systematic review of randomised trials. BMJ 2004 May 1; 328:1046-50.

http://gastroenterology.jwatch.org/cgi/content/full/2004/629/1