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

Minozzi 1997.

Methods This was a randomised, active‐controlled trial
Setting
Center for Climacteric and Menopause of the Institute of Obstetrics and Gynecology, Policlinico Umberto l, Rome, Italy
Date of study
Unspecified (12‐month duration)
Participants 63 women
Age = 52 to 63 years
 Inclusion criteria
  • Postmenopausal women with excessive hair loss as a predominant symptom.


Exclusion criteria
  • Hormonal therapy.

  • Endocrine diseases.

  • Drug intake.

  • Premenopausal alopecia.

  • Disease of the scalp.


Randomised
63 participants were randomised (group I = 21, group II = 21, group III = 21)
Withdrawals/losses to follow‐up
None were reported
Baseline data
Minimal data, blood tests: routine blood tests, serum follicle‐stimulating hormone (FSH), LH, estradiol, testosterone, free testosterone, dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulphate (DHEAS), delta‐4‐androstenedione, dihydrotestosterone, SHBG. Hormonal status consistent with menopause
Interventions Intervention
  • Group I = ethinyl estradiol (0.02 mg/day) on days 1 to 25 each month, a daily dose of 10 mg medroxyprogesterone acetate (MPA) added for the last 10 days of oestrogen administration. Repeated for 12 cycles.


Comparator 1
  • Group II = transdermal estradiol (0.05 mg/day) associated with medroxyprogesterone acetate (MPA) for the last 10 days of oestrogen administration. Repeated for 12 cycles.


Comparator 2
  • Group III = ethinyl estradiol (0.02 mg/day) on days 1 to 25 each month. A daily dose of 12.5 mg cyproterone acetate was added for the first the 10 days of oestrogen administration. Repeated for 12 cycles.

Outcomes Assessments (2): at baseline and month 12
Outcomes (as reported)
  • Hormonal assays.

  • Trichogram (with microscope).¹


¹Denotes outcomes prespecified for this review
Funding source None declared
Declaration of interest None declared
Notes Diagnosis of FPHL was not clearly defined/stated
We sent several e‐mails to the PI but received no response. None of our outcomes were assessed. See Table 8
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote (page 341): "The patients have been randomized in three equal groups to which a different treatment had been administered."
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.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk The study was open. The nature of the treatment interventions precludes any possibility of blinding of participants and personnel.
Comment: the outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk The study was open. The nature of the treatment interventions precludes any possibility of blinding of participants and personnel.
Comment: the outcome measurement is likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No dropouts were reported. It was unclear if data analysis was per‐protocol or intention‐to‐treat.
Comment: there was insufficient information to permit a clear judgement of risk of bias.
Selective reporting (reporting bias) Unclear risk The investigators did not report all of their prespecified outcomes of the hormonal screening (only SHBG), but it was uncertain to what extent the lack of data for other than SHBG had any impact on their reported results. Therefore, we judged this domain as at an unclear risk of bias.
Other bias Low risk Comment: the study appeared to be free of other forms of bias.