Faghihi 2008.
Methods | Within‐participant, randomised controlled trial This study was conducted in a secondary setting at 2 different centres in Iran |
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Participants | 47 participants with nearly symmetrical chronic hand eczema with a duration > 4 weeks No dropouts Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • 0.05% clobetasol + 2.5% zinc sulphate cream on 1 hand in 47 participants for 2 weeks • 0.05% clobetasol cream alone on the other hand in 47 participants for 2 weeks Duration 2 weeks |
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Outcomes |
Primary outcomes of the trial Not defined Other outcomes
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Notes | Overall severity of hand eczema was not an outcome. Use of the Mann‐Whitney U‐test for statistical analysis appears incorrect, as the data were related (within‐subject design) The secondary outcomes ‐ reduction in severity, participant‐rated, and time until relapse ‐ were included but did not provide reproducible data Study authors were contacted by mail on 28 February 2014 but remained unresponsive Declarations of interest: not stated Funding: the study was funded and supported by Isfahan University of Medical Sciences Sample size rationale: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "... right or left hand of them were randomised to be treated..." Comment: no further details given |
Allocation concealment (selection bias) | Unclear risk | No details about how allocation was concealed from participants and investigators |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the patients and investigators were blinded to type of treatment" Comment: the drugs were made in "similar shape" by a third party; this is considered an adequate way to blind participants Quote: "drugs were made by the Isfahan Pharmacy School in the similar shape, and the patients and investigators were blinded to the type of treatment" Comment: the code of drugs was revealed only at the end of the study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "drugs were made by the Isfahan Pharmacy School in the similar shape, and the patients and investigators were blinded to the type of treatment. The code of drugs was revealed only at the end of the study" Comment: no details regarding blinding of outcome assessors, although study authors mention a double‐blind design; this is insufficient information to judge the risk of bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "overall, 47 patients (94 samples) were evaluated and all of them completed the study" Comment: all participants completed the study and were included in the analyses |
Selective reporting (reporting bias) | Unclear risk | No trial registration found. All outcomes described in Subjects and Methods are described in the Results section, although for itch, only the statistical significance level is stated, but the other outcomes are stated in tables with exact numbers |
Other bias | Low risk | Baseline comparisons revealed no significant differences between groups in terms of erythema, scaling, lichenification, and pruritus; further within‐participant design Diagnostic certainty: yes The study was completed |