Assem 2016.
| Methods | Randomised clinical trial | |
| Participants | Country: Saudi Arabia and Egypt Period of recruitment: 2014–2015 Number randomised: 239 Postrandomisation dropouts: not stated Revised sample size: 239 Mean age (years): 57 Females: 63 (26.4%) Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): 56 (23.4%) Ascites with low protein: not stated Primary prophylaxis: 239 (100%) Alcohol‐related cirrhosis: not stated Viral‐related cirrhosis: 222 (92.9%) Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated Other causes for cirrhosis: 17 (7.1%) Treated for ascites in addition to antibiotics (e.g. albumin or diuretics): not stated Exclusion criteria:
|
|
| Interventions | Participants randomly assigned to 3 groups. Group 1: rifaximin + norfloxacin (n = 79) Further details: rifaximin 550 mg BD orally for 1 month, alternating with norfloxacin 400 mg OD for 1 month, total duration 6 months Group 2: norfloxacin (n = 78) Further details: norfloxacin 400 mg OD orally for 6 months Group 3: rifaximin (n = 82) Further details: rifaximin 550 mg BD orally for 6 months |
|
| Outcomes | Outcomes reported: all‐cause mortality; number of any adverse events per participant; proportion with spontaneous bacterial peritonitis (as per definition); number of other decompensation events Follow‐up (months): 6 |
|
| Notes | Attempted to contact authors in November 2018, but received no replies | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Enrolled patients were randomly allocated to three groups by using consecutively numbered, computer‐generated envelopes." |
| Allocation concealment (selection bias) | Low risk | Quote: "Enrolled patients were randomly allocated to three groups by using consecutively numbered, computer‐generated envelopes." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Open‐label" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Open‐label" |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: appeared some people were excluded from some outcomes, but information not clear. |
| Selective reporting (reporting bias) | Low risk | Comment: protocol not available, but authors reported mortality and adverse events adequately. |
| Other bias | Low risk | Comment: no other bias noted |