Rifaximin Alone vs. Combination with Norfloxacin for Secondary Prophylaxis of Spontaneous Bacterial Peritonitis with Hepatic Encephalopathy: Randomized Controlled Trial

Gut dysbiosis is the emerging concept that has been linked with complications of cirrhosis, such as SBP and HE. These events portend a poor prognosis for the patients.

Several studies have shown that rifaximin can reduce the oralisation of the gut microbiome and mucin degradation species in the gut. This helps in improving the gut microenvironment by reducing systemic inflammation caused by neutrophils and downregulation of TLR4 expression. On the other hand, due to the emergence of multidrugresistant organism (MDRO), gut-selective antibiotics with minimal systemic effects are needed.

Therefore, in this study, the effect of rifaximin vs. a combination of rifaximin with norfloxacin for secondary prophylaxis of patients of cirrhosis presenting with SBP and HE was evaluated. The primary outcomes of the study included recurrent episodes of SBP and HE at 6-month and 28-day, 90-day and 6-month mortality. Secondary outcomes included the number of rehospitalizations, new episodes of upper gastrointestinal (UGI) bleed, acute kidney injury and child-turcotte-pugh (CTP) and MELD over 6 months.

The key results and conclusion drawn from this study were: The mortality rates at 28 days, 90 days and 6 months were comparable between the two groups. Rehospitalization was higher in the combination group. Patients of cirrhosis with SBP and HE have a high inhospital mortality rate of up to 40%. Both the groups showed no significant difference in the recurrence rate of SBP and HE. Rifaximin has similar efficacy as a combination of rifaximin and norfloxacin for secondary prophylaxis of patients with SBP and HE.