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) |
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Participants | 63 women Age = 52 to 63 years Inclusion criteria
Exclusion criteria
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 |
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Interventions |
Intervention
Comparator 1
Comparator 2
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Outcomes | Assessments (2): at baseline and month 12 Outcomes (as reported)
¹Denotes outcomes prespecified for this review |
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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 |
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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. |