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  • Artigos Originais

    Placebo-controlled clinical trial with soy isoflavones for depressive symptoms in climacteric women

    Revista Brasileira de Ginecologia e Obstetrícia. 2006;28(2):91-100

    Summary

    Artigos Originais

    Placebo-controlled clinical trial with soy isoflavones for depressive symptoms in climacteric women

    Revista Brasileira de Ginecologia e Obstetrícia. 2006;28(2):91-100

    DOI 10.1590/S0100-72032006000200004

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    PURPOSE: to evaluate the efficacy of the use of isoflavones in the treatment of depressive symptoms in climacteric women. METHODS: placebo-controlled, randomized double-blind experimental study with 84 climacteric women who were assisted at the Lauro Wanderley University Hospital Ambulatory, in João Pessoa, Paraíba, Brazil. In the evaluation of the depressive symptoms the Self-evaluation questionnare of Hamilton's rating scale for depresion (QAEH-D) was used in the pretreatment visit (VT1), and in the 8th (VT2) and 16th (VT3) week after treatment. The experimental group (GExp) received soy extract with isoflavones, 120 mg per day, and the control group (GCont), placebo. The comparison of the scores of the QAEH-D between the VT1, VT2 and VT3 groups constituted the primary measure of efficacy (t test, p<0.05). Secondary analysis included the estimate of the "domino hypothesis" and the clinical and laboratory evaluation of side effects. RESULTS: there was a significant reduction of the QAEH-D scores in the GExp (VT20.05). From VT1 to VT3, there was a significant difference (8.9%) in the reduction of the scores between GExp and GCont (p=0.03). There was no correlation between the reduction of the depressive symptoms and alterations of the vasomotor symptoms (p>0.05). There was a reduction of FSH concentrations only in GExp (p=0.02), without estradiol modifications. Side effects were not clinically relevant. CONCLUSIONS: the effect of soy isoflavones was superior to the placebo, however, of small magnitude and only identified after 8 weeks of treatment. This small effect attributed to the experimental treatment, of good tolerability, may benefit patients who have side effects due to estradiol, or those who prefer not to use hormones.

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    Placebo-controlled clinical trial with soy isoflavones for depressive symptoms in climacteric women
  • Trabalhos Originais

    Test-retest Reliability in Application of the Blatt and Kupperman Menopausal Index

    Revista Brasileira de Ginecologia e Obstetrícia. 2000;22(8):481-487

    Summary

    Trabalhos Originais

    Test-retest Reliability in Application of the Blatt and Kupperman Menopausal Index

    Revista Brasileira de Ginecologia e Obstetrícia. 2000;22(8):481-487

    DOI 10.1590/S0100-72032000000800003

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    Purpose: based on the knowledge that the reliability of an instrument is essential for a correct interpretation of the results of research, the purpose of the present study is to evaluate the reliability of one of the menopausal indexes more often used in clinical practice and research, the Blatt and Kupperman Menopausal Index (BKMI). Methods: the population consisted of 60 climacteric patients attended at the Gynecology Outpatient Clinic of the Lauro Wanderley University Hospital of the Federal University of Paraíba in João Pessoa city. The reliability coefficient was analyzed by the test-retest method, whose application was done on two different occasions with an interval of four weeks, without administration of medicines. Results: the variation of the score observed with the application of BKMI at the first measurement was 2 to 41, with a median of 18 and mean of 18.8 (± 10.76), while at the second measurement, the menopausal index was 20.2 (± 10.51), median 19, and values ranging from 2 to 39. Despite these results, a Speaman (r s) coefficient of 0.68 (p = 0.001), which is a coefficient of only moderate intensity, was observed. Conclusions: the test-retest reliability in the application of the BKMI shows that, although this instrument presented a statistically moderate reliability, the intensity observed does not represent a reliable measurement. Considering that a correlational study is only a type of screening of the quality of a measurement method, we concluded that other studies must be performed with the purpose of evaluating the reliability and the validity of the BKMI. It is possible that the attribuition of different values to the items of BKMI and the inclusion of symptoms directly related to the estrogenic defficiency, like symptoms of vaginal atrophy, would make the instrument more reliable.

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    Test-retest Reliability in Application of the Blatt and Kupperman Menopausal Index

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