Patients with cirrhosis were less likely to develop overt hepatic encephalopathy when taking probiotics than controls in a study presented at the International Liver Congress in Amsterdam.
Researchers randomly assigned 160 patients without a history of overt hepatic encephalopathy (HE) to receive probiotic VSL#3 three times daily (n=86) or serve as controls (n=74). Patients received critical flicker frequency (CFF) and psychometric tests, and underwent lactulose hydrogen breath testing (LHBT) to assess oro-cecal transit time (OCTT) and glucose hydrogen breath testing (GHBT) to determine the presence of small intestinal bacterial overgrowth (SIBO).
Incidence of minimal (MHE) and overt HE was observed within the cohort over a mean follow-up of 28.5 ± 11.8 weeks for treated patients and 27.3 ± 12.8 weeks among controls. Eleven patients were lost to follow-up, and six treated participants and seven controls died during the study (P=.81).
Among evaluable participants, MHE was indicated in 48.8% of probiotic recipients and 44.6% of controls (P=.88). Significantly more patients in the control group developed overt HE during follow-up compared with treated patients (20.3% vs. 8.8%; HR=2.1; 95% CI, 1.31-6.53). After 3 months, significant improvements were observed among treated patients in the presence of MHE and SIBO, as well as OCTT and psychometric HE scores and CFF test results.
Investigators calculated absolute risk reductions for overt HE of 23.8% (95% CI, 5.4%-42.2%) among those with MHE and 7.8% (95% CI, 2.2%-11.4%) among those without MHE, with a number needed to treat of 5.1 (95% CI, 2.4-18.4) and 31 (95% CI, 14.2-58.6), respectively.
“Hepatic encephalopathy is an insidious disease,” Mauro Bernardi, MD, treasurer of the EASL, said in a press release. “Treatment normally involves the use of antibiotics or laxatives to suppress the production of toxic substances in the intestine, but there is still a great deal of room for improvement so it will be exciting to see the results of further studies to determine if clinicians have a new form of treatment [in] the cards.”
For more information:
Lunia MK. #78: An Open-Label Randomized Controlled Trial of Probiotics For Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis. Presented at: The International Liver Congress 2013; April 24-28, Amsterdam.