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. 2017 Nov 3;2017(11):CD011564. doi: 10.1002/14651858.CD011564.pub2

Shiomi 1999b.

Methods Randomised clinical trial with parallel group design (2 groups).
Participants 34 women, aged 36 to 72 years, mean age 56 years, with primary biliary cirrhosis.
Inclusion criteria: primary biliary cirrhosis.
Exclusion criteria: none stated.
Interventions Intervention: calcitriol 0.5 μg twice a day (n = 17).
Control: no intervention (n = 17).
For 1 year.
Outcomes Outcomes reported in abstract of publication.
Primary outcome: bone mineral density.
Secondary outcomes: none stated.
Stated aim of study To evaluate efficacy of calcitriol (1,25‐dihydroxyvitamin D) in treatment of bone disease associated with primary biliary cirrhosis.
Notes Additional information received through personal communication with authors on 12 February 2014.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of sequence generation not specified.
Allocation concealment (selection bias) Unclear risk Method used to conceal allocation not described so that intervention allocations may have been foreseen in advance of, or during, enrolment.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding, and outcome was likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No blinding of outcome assessment, and outcome measurement was likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Missing data were unlikely to make treatment effects depart from plausible values.
Selective reporting (reporting bias) High risk Not all predefined outcomes reported fully.
For‐profit bias Unclear risk Trial may or may not have been free of for‐profit bias as no information on clinical trial support or sponsorship was provided.
Other bias Unclear risk Trial may or may not have been free of other components that could put it at risk of bias.