Zienicke 1993
Methods | Individual randomised controlled trials | |
Participants | Dx: SD; participants must be 16 years of age and older Excluded: pregnant persons, HIV-positive persons, those with allergy to imidazoles, those given topical treatment 2 weeks before start of study, etc |
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Interventions | Intervention: 1% bifonazole ointment applied once daily to the face for 28 days (n = 45) Control: vehicle applied similarly (n = 47) |
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Outcomes | Total remission of symptoms, symptom severity score | |
Notes | Country: Germany; no conflict of interest; side effects: Unwanted effects were recorded 7 times in the bifonazole group and 4 times in the control group. No mention is made of the actual number of participants in each group who were affected. Side effects included itch, erythema, tightness of the skin, burning, papules and scaling | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "One hundred patients were enrolled and treated according to a random plan ... This was a controlled, double-blind multi centre trial ..." |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Baseline comparable? | Unclear risk | "There were no differences between the verum-treated group and the control group in terms of age ..." |
Patient blinded? | Unclear risk | "... double blind ..." |
Provider blinded? | Unclear risk | "... double blind ..." |
Outcome assessor blinded? | Unclear risk | "... double blind ..." |
Co-interventions avoided? | Unclear risk | Not reported |
Compliance acceptable? | Unclear risk | Not reported |
Drop-out acceptable? | Low risk | Bifonazole (17%), vehicle (8.51%) |
Selective outcome reporting acceptable? | Unclear risk | Not reported |
ITT? | High risk | 92 participants were evaluated in all; totals provided in tables show that ITT analysis was not done |