Picciotto 1994.

Methods	Generation of allocation sequence: unclear (no description). Allocation concealment: adequate (sealed envelopes). Double blinding: inadequate (not blinding). Sample size calculation: no information. Follow up: adequate (two patients in each group). Intention‐to‐treat analysis: yes.
Participants	Country: Italy. Type of hepatitis: chronic hepatitis C. INCLUSION CRITERIA: ‐ anti‐HCV positive; ‐ biopsy‐proven chronic hepatitis; ‐ ALT activities persistently greater than two times the upper normal limit. EXCLUSION CRITERIA: ‐ autoimmune hepatitis, alcoholic‐ or drug‐related liver diseases, hemochromatosis, Wilson's disease, or alpha‐1‐antitrypsin deficiency; ‐ bilirubin levels > three mg/dl, albumin levels< three g/dL, prothrombin time > three seconds longer than that of normal value, serum creatinine levels > 1.7 mg%, platelet count < 100,000/µl, granulocyte count < 1500/µl. PARTICIPANTS ‐ TUDCA plus IFN group (n = 30): Mean age (years+/‐ SD) 49.4+/‐11.3. Ratio of sex (M/F) 23/7. ‐ IFN group (n = 30): Mean age (years+/‐ SD) 49.5+/‐16; Ratio of sex (M/F) 21/9.
Interventions	TUDCA plus IFN group: TUDCA ‐ Dose: 500 mg/day; ‐ Route: orally; ‐ Timing: two times a day; ‐ Duration: nine months. IFN IFN alpha‐2b ‐ Dose: three million units; ‐ Route: subcutaneously; ‐ Timing: three times per week; ‐ Duration: six months. IFN group: IFN alpha‐2b ‐ Dose: three million units; ‐ Route: subcutaneously; ‐ Timing: three times per week; ‐ Duration: six months.
Outcomes	‐ Normalisation of serum ALT at the end of treatment and follow‐up.
Notes	Follow‐up time: three months after the end of IFN treatment.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate