Price 1990.
Methods | This was a randomised, double‐blind, placebo‐controlled trial Setting Departments of Dematology of Kaiser Permanente Medical Center and University, San Francisco, and Trichos Research, Richmond, USA Date of study Unreported (40‐week duration) |
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Participants | 9 women Age = 22 to 41 years Inclusion criteria
Exclusion criteria
Randomised 9 participants were randomised (minoxidil group = 5, placebo group = 4) Withdrawals/losses to follow‐up There was 1 withdrawal in the minoxidil group due to hyperprolactinaemia Baseline data Degree of thinning Ludwig scale (participants by grade, intervention group)
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Interventions |
Intervention
Comparator
The study duration was 40 weeks, and treatment was started after the 2nd visit at 4 weeks from baseline |
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Outcomes | Assessments (6): at baseline and at 8‐week intervals Outcomes (as reported)
¹Denotes outcomes prespecified for this review |
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Funding source | Quote (page 683): "The Upjohn Company provided support and encouragement of this research." | |
Declaration of interest | None declared | |
Notes | Individual patient data were reported, but there were small sample sizes | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote (page 684): "The subjects were given test solutions in a random, double‐blind manner." 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 risk of bias. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote (page 683): "double‐blind protocol". 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 of risk of bias. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | There was insufficient information to permit a clear judgement of the risk of bias. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There was a small number of withdrawals: 1/9 in the minoxidil group (hyperprolactinaemia). Individual patient data were reported. 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. |