Tursi 2007a.
Methods | RCT, single‐centre, Italy | |
Participants | 30 patients with uncomplicated acute diverticulitis after remission, mean 60.1 years, 19 males, 11 female | |
Interventions | 5‐ASA balsalazide 2.25 g once daily for 10 days every month plus probiotic VSL#3 450 billions/d for 15 days every month vs probiotic alone (VSL#3) 450 billions/d for 15 days every month. Remission was induced with rifaximin 800 mg/d and 5‐ASA 2.25 g/d for 10 days. Follow‐up: 12 months |
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Outcomes | Maintainence of remission after an attack, overall scores at end of follow‐up, single symptom assessment, adverse events | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | "the patients who met inclusion criteria were enrolled in the study and randomised, in an unblinded fashion, one to one into the two groups of treatments, after giving their informed consent" It is likely allocation was not concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Randomised in an "unblinded" fashion. Treatment regimens were different, no placebo was used, likely participants and physicians were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described but probably not done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant from each group lost to follow‐up |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | None found |
5‐ASA: 5‐aminosalicylic acid. ITT: intention‐to‐treat. RCT: randomised controlled trial. TIQ: Therapeutic Impact Questionnaire.