Price 2000.
Methods | This was a randomised, double‐blind, placebo‐controlled trial Setting 8 investigational sites in the USA Date of study Unreported (12‐month duration) |
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Participants | 137 women Mean age (range) = 53 years (41 to 60) Inclusion criteria
Exclusion criteria Nothing was reported Randomised 137 participants were randomised (finasteride group = 67, placebo group = 70) Withdrawals/losses to follow‐up There were 12/137 (8.8%) withdrawals/losses to follow‐up: 5/67 (7.5%) in the finasteride group, and 7/70 (10%) in the placebo group
Baseline data Mean baseline hair count measured in a 1 cm² circular area at the anterior/mid area of the scalp ± SD
Savin score (number [%] of women)
Ludwig scale (number (%) of women)
Concomitant hormone replacement therapy (number (%) of women)
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Interventions |
Intervention
Comparator
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Outcomes | Assessments (6): at baseline, 1, 3, 6, 9, and 12 months Primary outcomes (as reported)
Secondary outcomes (as reported)
¹Denotes outcomes prespecified for this review |
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Funding source | Quote (page 768): "supported by Merck Research Laboratories." | |
Declaration of interest | None declared but almost half of the investigators indicated an affiliation with Merck Research Laboratories | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote (page 769): "randomized to receive either". 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 769): "double‐blind". 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 | Quote (page 770): "At the end of the study, an expert panel of 3 dermatologists (E. Olsen, R. Savin, and D. Whiting), blinded as to treatment, independently evaluated hair growth or loss by comparing baseline photographs." Comment: participants and the 3 dermatologists (investigators) were assessors for several outcomes, and, although stated to be "blinded", the measures used were not reported. There was insufficient information to permit clear judgement of bias across all outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were 12/137 (8.8%) dropouts; and the reasons were reported. Intention‐to‐treat analysis (ITT) analysis was done. Comment: we judged this as at a low risk of bias. |
Selective reporting (reporting bias) | Low risk | The study protocol was unavailable, but the study appeared 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. |