Keene 2011.
Methods | This was a randomised, blinded, sham‐controlled trial Setting Unspecified USA Date of study December 2008 to December 2009 (6‐month duration) |
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Participants | 13 women Mean age (SD) = not reported Inclusion criteria
Exclusion criteria
Randomised 13 participants were randomised (finasteride group = 8, placebo group = 5) Withdrawals/losses to follow‐up None were reported Baseline data None reported |
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Interventions |
Intervention
Comparator
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Outcomes | Assessments (7): at baseline and every month Outcomes of the trial (as reported)
¹Denotes outcomes prespecified for this review |
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Funding source | Quote (page 268): "study was funded by DermaGenoma, Inc" | |
Declaration of interest | Quote (page 268): "Both authors are employed by DermaGenoma, Inc" | |
Notes | Study participants used buccal swabs to obtain DNA for identification of their AR gene polymorphism. This involved evaluation of the number of CAG nucleotide repeats in the first exon of the AR gene in each X chromosome. Subsequently, each participant who was not homozygous in the AR‐CAG allele underwent determination of percentage of X inactivation for each allele based on the method of quantitative polymerase chain reaction (PCR) product (inactive allele) following digestion of unmethylated (activated) DNA | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote (page 297): "Patients who met the inclusion criteria were randomized to either placebo or 1‐mg finasteride". 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. After e‐mail communication: "For each subject, the site supervisor picked from a bowl a random letter A or B". Comment: this was probably done. |
Allocation concealment (selection bias) | Low 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. After e‐mail communication: "The study was conducted for a sponsor. The sponsor recruited an independent site monitor (Registered Nurse) who had the sole access to the information during the course of the study". Comment: this is a form of central allocation, which was probably done. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote (page 297): "6‐month blinded". 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. After e‐mail communication: "Tablets were compounded at a pharmacy to look exactly the same". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (page 297): "6‐month blinded". Comment: there was uncertainty with effective blinding of outcomes assessors (participants/healthcare providers) during the study. There was insufficient information to permit a clear judgement. After e‐mail communication: "Tablets were compounded at a pharmacy to look exactly the same". Comment: it was unlikely that the blinding was broken. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts were reported and data are available for all individual participants. Comment: we judged this as at low risk of bias. |
Selective reporting (reporting bias) | Low risk | The protocol for the study was available on clinicaltrials.gov (NCT01052870). The trial appeared to report 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. |