Dias Rodrigo S, Kerr-Corrêa Florence, Moreno Ricardo A, Trinca Luzia A, Pontes Anagloria, Halbe Hans W, Gianfaldoni Arlete, Dalben Ivete S
Department of Neurology and Psychiatry, Botucatu Medical School, São Paulo, Brazil.
Menopause. 2006 Mar-Apr;13(2):202-11. doi: 10.1097/01.gme.0000198491.34371.9c.
This study evaluated the augmentation of venlafaxine with hormone therapy in the treatment of postmenopausal depression. The hormones evaluated were estrogen (0.625 mg) in combination with medroxyprogesterone acetate (2.5 mg) and methyltestosterone (2.5 mg).
Seventy-two menopausal women (mean age: 53.6 +/- 4.27 years) diagnosed with depression (Montgomery-Asberg Depression Rating Scale [MADRS] scores > or = 20) were treated with venlafaxine and one of the following hormone therapy combinations, in a double-blind regimen: estrogen + medroxyprogesterone + methyltestosterone (group 1, n = 20); estrogen + medroxyprogesterone acetate (group 2, n = 20); methyltestosterone only (group 3, n = 16); and no hormone therapy (group 4, n = 16). Study duration was 24 weeks. Primary efficacy outcome was remission according to the MADRS, whereas secondary efficacy measures included the Clinical Global Impression (CGI), Blatt-Kupperman Index, and Women's Health Questionnaire (WHQ).
Forty-eight patients completed the study. All groups showed significant improvement from baseline. Group 3 demonstrated significant improvement on the MADRS compared with placebo (group 4) at weeks 20 (P = 0.048) and 24 (P = 0.030); effect size 8.04 (0.83; 15.26) (P = 0.029), but also had the highest dropout rate. Groups 1 and 3 had significant CGI improvement rates compared with placebo: 42.23% (P = 0.012) and 44.45% (P = 0.08), respectively. There were no differences in the WHQ or BKI scores among the groups.
Methyltestosterone 2.5 mg had the highest effect size compared with placebo, but the high dropout rate prevented its efficacy from being determined. Estrogen plus medroxyprogesterone, combined with methyltestosterone or otherwise, demonstrated a trend toward increased efficacy of venlafaxine. Further larger-scale clinical trials are needed to elucidate the findings of this pilot study.
本研究评估了文拉法辛联合激素疗法治疗绝经后抑郁症的效果。所评估的激素为雌激素（0.625毫克）联合醋酸甲羟孕酮（2.5毫克）以及甲基睾酮（2.5毫克）。
72名被诊断为抑郁症（蒙哥马利-阿斯伯格抑郁评定量表[MADRS]评分≥20）的绝经后女性（平均年龄：53.6±4.27岁）接受文拉法辛及以下激素疗法组合之一的治疗，采用双盲方案：雌激素+甲羟孕酮+甲基睾酮（第1组，n = 20）；雌激素+醋酸甲羟孕酮（第2组，n = 20）；仅用甲基睾酮（第3组，n = 16）；以及不进行激素治疗（第4组，n = 16）。研究持续时间为24周。主要疗效指标是根据MADRS达到缓解，而次要疗效指标包括临床总体印象（CGI）、布拉特-库珀曼指数和女性健康问卷（WHQ）。
48名患者完成了研究。所有组与基线相比均有显著改善。第3组在第20周（P = 0.048）和第24周（P = 0.030）时，与安慰剂组（第4组）相比，MADRS有显著改善；效应量为8.04（0.83；15.26）（P = 0.029），但其脱落率最高。第1组和第3组与安慰剂相比，CGI改善率显著：分别为42.23%（P = 0.012）和44.45%（P = 0.08）。各组之间WHQ或BKI评分无差异。
与安慰剂相比，2.5毫克甲基睾酮的效应量最高，但高脱落率使其疗效无法确定。雌激素加甲羟孕酮，联合或不联合甲基睾酮，显示出文拉法辛疗效增加的趋势。需要进一步开展更大规模的临床试验来阐明本初步研究的结果。
