De la Mora 1994.
Methods | Randomised trial. Follow‐up: information not provided. |
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Participants | Patients with PBC (n = 28) from one centre in Mexico. | |
Interventions | Experimental: ursodeoxycholic acid (details were not given). Control: placebo. |
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Outcomes | Serum cholesterol. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The trial is described as randomised, but the method of sequence generation was not specified. |
Allocation concealment (selection bias) | Unclear risk | The trial was described as randomised but the method used to conceal the allocation was not described, so that intervention allocations may have been foreseen in advance of, or during, enrolment. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | 'Placebo' employed, but it is not known if it was indeed double blind. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The report gave the impression that there had been no dropouts or withdrawals, but this was not specifically stated. |
Selective reporting (reporting bias) | Unclear risk | Not all pre‐defined, or clinically relevant and reasonably expected outcomes are reported on or are not reported fully, or it is unclear whether data on these outcomes were recorded or not. |
Other bias | Unclear risk | The trial may or may not be free of information that could put it at risk of bias. |