Gambichler 2001.
Study characteristics | ||
Methods | Two‐group parallel split‐body, randomised controlled trial with paired comparison of right versus left elbow
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Participants |
Inclusion criteria of the trial
Exclusion criteria of the trial
Characteristics
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Interventions |
Intervention (n = 10, one elbow)
Control intervention (n = 10, the other elbow)
Both elbows were simultaneously exposed to the solution by bandaging the sites with soaked cotton wool. The interventions were applied to both elbows once a day, three to five days a week, for up to eight weeks, and reaching a maximum number of 30 applications. Duration of UV irradiation was not reported. |
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Outcomes |
Outcomes of the trial not classified as primary or secondary
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Notes | Funding not reported Conflicts of interest: issue not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote (page 22): "A prospective, randomized, one‐blind, right/left comparison, investigating the efficacy of BPT in psoriasis with highly concentrated salt water versus tap water, was performed in an out‐patient setting during autumn and winter." Comment: sequence generation not clear |
Allocation concealment (selection bias) | Unclear risk | Comment: allocation concealment not clear |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote (page 22): "A prospective, randomized, one‐blind, right/left comparison, investigating the efficacy of BPT in psoriasis with highly concentrated salt water versus tap water, was performed in an out‐patient setting during autumn and winter." "Both elbows were simultaneously exposed to these liquids (30°C) by bandaging the sites with soaked cotton wool." Comment: partially blinding of people or limbs |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (page 23): "To avoid interobserver variation, all patients were clinically assessed by one physician who was not informed which pretreatment had been used prior to phototherapy." Comment: blinding of outcome assessment achieved |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: we did not identify a noteworthy proportion of dropouts and judged a low risk of attrition bias. |
Selective reporting (reporting bias) | Unclear risk | Comment: we did not identify a selective reporting issue and judged an unclear risk of bias. |
Other bias | Unclear risk | Comment: we did not identify other bias such as design‐specific risks of bias, baseline imbalance, blocked randomisation in unblinded trials, and differential diagnostic activity. |