Olsen 1991.
Methods | This was a randomised, double‐blind, placebo‐controlled trial Setting Duke University Medical Center, Durham, USA Date of study Not reported (32‐week duration) |
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Participants | 30 women Mean age (range) = 36.0 years (19 to 45) in the minoxidil group, 38.9 years (33 to 43) in the placebo group Inclusion criteria
Exclusion criteria
Randomised 30 participants were randomised (15 to each of 2 groups) Withdrawals/losses to follow‐up There were 2/30 (6.7%) (1/group) withdrawals/losses to follow‐up. The time and reasons were unreported Baseline data Duration of hair thinning in mean (SD) years
Degree of thinning Ludwig scale (participants by grade and group)
Number of non‐vellus hairs in the target area, mean (SD)
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Interventions |
Intervention
Comparator
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Outcomes | Assessments (9): at baseline, 4, 8, 12, 16, 20, 24, 28, and 32 weeks
Primary outcomes (as reported)
Secondary outcomes (as reported)
¹Denotes outcomes prespecified for this review |
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Funding source | Quote (page 248): "This work was supported in part by a grant from the Upjohn Company" | |
Declaration of interest | None declared | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote (page 243): "were randomly assigned to apply". Comment: the trial authors did not report the method used to generate the allocation sequence in sufficient detail to allow a clear assessment of whether it would produce comparable groups. |
Allocation concealment (selection bias) | Unclear risk | The trial authors did not report the method used to conceal the allocation sequence, that is to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment. Comment: there was insufficient information to permit a clear judgement of the risk of bias. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote (page 244): "Both subjects and investigators remained blinded during the entire study." Comment: the report did not provide sufficient detail about the measures used to blind study participants and personnel from knowledge of which intervention a participant received, to permit a clear judgement. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (page 245): "One technician at Duke University Medical Center blinded as to treatment counted the nonvellus target areas hairs on each set of before and after photographs." Comment: this was probably done. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There was a balanced and low number (1 in each group) of losses to follow‐up. The data analysis was per‐protocol. Comment: we judged this as at a low risk of bias. |
Selective reporting (reporting bias) | Low risk | The protocol for the study was unavailable, but the trial appears to have reported the prespecified outcomes and those mentioned in the methods section. Comment: we judged this as at a low risk of bias. |
Other bias | Low risk | Comment: the study appeared to be free of other forms of bias. |