Guerrero 2009.
Methods | This was a randomised, active‐controlled trial Setting 3 centres in Chile Date of study November 2007 to April 2008 (12‐week duration) |
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Participants | 40 men and women (22 men, 18 women) Mean age = 43.7 years (range 20 to 69) Inclusion criteria
Exclusion criteria
Randomised 40 participants were randomised (minoxidil group = 15, estradiol group 18, unclear = 7) Withdrawals/losses to follow‐up 7/40 (18%) withdrawals/losses to follow‐up: unclear how many from each group
Baseline data Most men had Hamilton II/III and most women Ludwig II |
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Interventions |
Intervention
Comparator
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Outcomes | Assessments (4): at baseline, days 30, 60, and 90 Outcomes of the trial (as reported)
¹Denotes outcomes prespecified for this review |
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Funding source | None declared | |
Declaration of interest | None declared | |
Notes | The sample comprised of participants of both genders, and the sequence was generated according to simple randomisation (specific method unreported, but without stratification). The results did not consider gender as a factor or covariate, and the data reported and subsequent analysis is not gender‐specific. We e‐mailed the PI, but received no response. See Table 8 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote (page 22): "un estudio randomizado" and "en forma aleatoria mediante randomización simple en dos grupos" (randomised through simple randomisation). 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 method used to conceal the allocation sequence, that is to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment, was not reported. 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 22): "triple ciego" (triple‐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. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote (page 22): "triple ciego" (triple‐blind). Comment: uncertainty with the effectiveness of blinding of outcomes assessors (participants, healthcare providers) during the study. There was insufficient information to permit a clear judgement. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 7/40 (18%) withdrawals/losses to follow‐up: unclear how many from each group. The data analysis was per‐protocol. Comment: although the numbers of dropouts appear balanced between the groups, the percentage of dropouts and subsequent per‐protocol analysis poses an unclear 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. |