Veien 1999.
Methods | Parallel‐group (3 groups), randomised controlled trial This study was conducted in a secondary care setting at 3 centres in Denmark (study was carried out at a university department as well as at 2 private dermatology clinics) |
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Participants | 106 participants were randomised (all patch tested) with hand eczema > 6 months that had cleared upon daily treatment for a maximum of 9 weeks with mometasone furoate cream 120 participants were recruited, and 14 dropped out during the initial phase No dropouts after randomisation (see notes) Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • Mometasone furoate cream thrice weekly (Sunday/Tuesday/Thursday) for up to 36 weeks or 30 (?) in 35/35 participants • Mometasone cream twice weekly (Saturday/Sunday) for up to 36 weeks in 37/37 participants Control intervention • No corticosteroids in 34/34 participants Emollients (Essex cream and ointment) used in all groups In case of recurrence, all groups were permitted to use mometasone daily for a maximum of 3 weeks at separate period Additional treatment was permitted in all groups in case of a bacterial infection Duration Up to 36 weeks |
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Outcomes |
Primary outcome of the trial
Other outcomes
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Notes | All randomised participants were supposed to be free of eczema due to preceding treatment (induction of remission) with mometasone, yet recurrence was defined as a score equal to or higher than before this remission induction phase. In each group, a few participants received additional treatment. Dropout was defined as participant who had more than 2 recurrences The secondary outcome ‐ time until relapse ‐ was included in the study, but data were not reproducible Study authors were contacted on 7 March 2014 but responded on 13 March 2014 that they were unable to provide additional information Declarations of interest: not stated Funding: Schering‐Plough A/S Farum, Denmark, supplied the study drugs and covered the expenses of processing the data Sample size rationale: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients.... were randomised into 1 of 3 groups" Comment: no further details in the article. Personal contact with the study author clarified that the randomisation table was computer generated with blocks of 5, and this was carried out by Schering‐Plough A/S, Farum, Denmark |
Allocation concealment (selection bias) | Low risk | No details in the article about how allocation was concealed from participants and clinicians; however personal contact with study authors clarified that randomisation was created by a third party. The investigators received sealed and numbered envelopes for allocation to a treatment arm |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "ideally, the maintenance phase should have been double‐blind. This would, however, have required a very complicated distribution of the medicaments, with many different tubes for various days of the week. We felt the risks of mistakes by the patients and of poor compliance to be too great" Comment: no blinding; blinding was difficult because participants had to follow different treatment schedules |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "the investigation was carried out as an open, prospective, randomized trial" Comment: no blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "the intention‐to‐treat principle was used to calculate the effect of the treatments" Comment: intention‐to‐treat analysis |
Selective reporting (reporting bias) | Low risk | No trial registration found. Severity of pruritus, erythema and vesicles, scaling, and fissures is described in the Materials and Methods section, but separate results for these are not given in the Results section; however, because these are not listed as outcome, we judged this as low risk. All (clearly described) outcomes listed in the Materials and Methods section are included in the Results section |
Other bias | Low risk | Baseline comparisons: "there were no statistically significant differences in the demographic features represented in the 3 centres or in the 3 randomisation groups" Diagnostic certainty: yes The study was completed |