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. 2016 May 26;2016(5):CD007628. doi: 10.1002/14651858.CD007628.pub4

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)
Participants 137 women
Mean age (range) = 53 years (41 to 60)
Inclusion criteria
  • < 59 years of age in good physical and mental health, postmenopausal (and amenorrhoeic > 1 year, but > 10 years).

  • Serum follicle‐stimulating hormone (FSH) level of > 40 mIU/mL.

  • Mild to moderate frontal hair thinning Ludwig scale grade I or II (Ludwig 1977); and Savin female density scale 3, 4, or 5 (Trancik 1996).


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
  • Clinical adverse event: finasteride group = 2, placebo group = 1.

  • Lost to follow‐up: finasteride group = 1, placebo group = 3.

  • Withdrew consent: finasteride group = 0, placebo group = 3.

  • Noncompliance: finasteride group = 1, placebo group = 0.

  • Lack of efficacy: finasteride group = 1, placebo group = 0.


Baseline data
Mean baseline hair count measured in a 1 cm² circular area at the anterior/mid area of the scalp ± SD
  • Finasteride group = 151 ± 49, placebo group = 164 ± 53.


Savin score (number [%] of women)
  • 3: finasteride group = 21 (31.3), placebo group = 30 (42.9).

  • 4: finasteride group = 30 (44.8), placebo group = 21 (30.0).

  • 5: finasteride group = 16 (23.9), placebo group = 19 (27.1).


Ludwig scale (number (%) of women)
  • Grade I: finasteride group = 22 (32.8), placebo group = 31 (44.3).

  • Grade II: finasteride group = 45 (67.2), placebo group = 39 (55.7).


Concomitant hormone replacement therapy (number (%) of women)
  • Finasteride group = 35 (52.2), placebo group = 37 (52.9).

Interventions Intervention
  • Oral finasteride 1 mg/day during 12 months.


Comparator
  • Placebo during 12 months.

Outcomes Assessments (6): at baseline, 1, 3, 6, 9, and 12 months
Primary outcomes (as reported)
  • Hair counts, computer‐assisted scans of macro‐photographs of clipped hair in a defined (dot tattoo) circular target area (1 cm²) frontal/parietal (anterior/mid) scalp. Macro‐photographs converted into dot maps at baseline and at months 3, 6, and 12.¹


Secondary outcomes (as reported)
  • Participant/self‐assessed hair growth, modified version of a validated questionnaire (4 questions: appearance of hair, growth of hair, slowing down of hair loss, and satisfaction with appearance of hair) (Barber 1998).¹

  • Investigator‐assessed hair growth, a standardised 7‐point rating scale (−3 = greatly decreased to +3 = greatly increased).¹

  • Scalp biopsies; terminal hair bulbs; terminal anagen, catagen, and telogen hairs; and vellus and vellus‐like (miniaturised) hair counts.

  • Laboratory tests; haematology, urinalysis, serum chemistry, hormone analysis, and bone marker analyses.


¹Denotes outcomes prespecified for this review
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.