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. |
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Interventions |
Intervention: calcitriol 0.5 μg twice a day (n = 17). Control: no intervention (n = 17). For 1 year. |
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Outcomes | Outcomes reported in abstract of publication. Primary outcome: bone mineral density. Secondary outcomes: none stated. |
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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. |