Ma 2016.
Methods | Randomised clinical trial. | |
Participants | Country: China. Number randomised: 199. Post‐randomisation dropouts: 8 (4.0%). Revised sample size: 191. Mean age: 51 years. Females: 167 (83.9%). Symptomatic participants: 38 (19.9%). AMA positive: 187 (97.9%). Responders: not stated. Mean follow‐up period (for all groups): all participants: 6 months. Inclusion criteria
Exclusion criteria
|
|
Interventions | Participants were randomly assigned to 2 groups. Group 1: UDCA (moderate) (n = 66). Further details: UDCA: 250 mg 3 times daily for 24 weeks. Group 2: TUDCA (moderate) (n = 125). Further details: TUDCA: 250 mg 3 times daily for 24 weeks. |
|
Outcomes | Adverse events. | |
Notes | Reason for drop‐outs: not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A centralized telecommunication‐based interactive voice response system was used for patient randomization after patient eligibility was determined through clinical and laboratory screening assessments". |
Allocation concealment (selection bias) | Low risk | Quote: "A centralized telecommunication‐based interactive voice response system was used for patient randomization after patient eligibility was determined through clinical and laboratory screening assessments". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: identical placebo used in this double‐blind trial. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: identical placebo used in this double‐blind trial. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: unclear whether all participants were included in the analysis. |
Selective reporting (reporting bias) | High risk | Comment: mortality not reported. |
For‐profit bias | High risk | Quote: "This study was sponsored by the Beijing Trendful Kangjian Medical Information Consulting Co., Ltd. and the Major Science and Technology Special Project of China Twelfth Five‐year Plan (2012ZX10002003). Registration Number: NCT01829698". |
Other bias | Low risk | Comment: no other source of bias. |