Allison 1986.
Methods | Randomised clinical trial. | |
Participants | Country: UK.
Number randomised: 17.
Post‐randomisation drop‐outs: 6 (35.3%).
Revised sample size: 11.
Mean age: 52 years.
Females: 3 (27.3%). Ulcerative colitis: no. Inclusion criteria:
Exclusion criteria:
Follow‐up: 3 months after completion of 2‐week treatment. |
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Interventions | Participants were randomly assigned to 1 of 2 groups. Group 1: continuous nasobiliary irrigation with normal saline plus hydrocortisone (100 mg/d) for 2 weeks (n = 6). Group 2: continuous nasobiliary irrigation with saline alone (1 L/d) for 2 weeks (n = 5). | |
Outcomes | 1. Mortality. 2. Proportion of participants with any type of adverse events. 3. Proportion of participants with severe adverse events. 4. Number of any type of adverse events. 5. Number of severe adverse events. 6. Liver transplantation. | |
Notes | Reasons for post‐randomisation drop‐out: "technical failures":
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomised by sealed envelope to receive continuous nasobiliary irrigation with either normal saline alone or normal saline plus hydrocortisone. [.] The randomisation code was blocked to ensure an approximately equal number of patients in each group at any stage of the trial". |
Allocation concealment (selection bias) | Low risk | Quote: "Patients were randomised by sealed envelope". Comment: "Opaque sealed envelopes manually shuffled" (trial author's reply). |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Patients and interpreters blinded to allocation" (trial author's reply). |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Patients and interpreters blinded to allocation" (trial author's reply). |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: Post‐randomisation drop‐outs may be related to the treatment that participants received. |
Selective reporting (reporting bias) | Low risk | Comment: No published protocol was available; mortality and liver transplantation were reported. |
For‐profit bias | Low risk | Comment: "Patients were cared for and followed within normal NHS founded hospital stay. No additional grants were sought" (trial author's reply). |
Other bias | Low risk | Comment: no other bias. |