Simon James A, Chandler Julie, Gottesdiener Keith, Lazarus Nicole, He Weili, Rosenberg Elizabeth, Wagner John A, Denker Andrew E
From the 1George Washington University and Women's Health and Research Consultants, Washington, DC; and 2Merck & Co Inc, Whitehouse Station, NJ.
Menopause. 2014 Sep;21(9):938-44. doi: 10.1097/GME.0000000000000218.
This trial examined diaries of hot flash events reported upon occurrence to assess the test/retest reliability of the diaries and their ability to measure treatment effects on hot flash frequency and severity.
Forty-two postmenopausal women (aged ≥40 y; 5-50 hot flashes/wk) were randomized (3:3:1) to placebo, raloxifene 60 mg, or paroxetine 20 mg daily for 12 weeks. Diaries of hot flash frequency and severity were evaluated at 1-week intervals (twice before study treatment and thrice during study treatment).
Forty-one women were evaluated. Baseline characteristics were similar between groups (eg, mean, 29.8 hot flashes/wk). Concordance correlation coefficients between screening (week -2) and baseline (week -1) measures of hot flash frequency and severity were 0.73 and 0.71, respectively. After 12 weeks, the mean (95% CI) percent changes from baseline in weekly hot flash frequency were as follows: placebo, -37.4% (-60.9 to -14.0); raloxifene, -14.2% (-37.7 to 9.3); paroxetine, -49.8% (-88.6 to -11.0); the mean (95% CI) percent changes in hot flash severity were as follows: placebo, -39.9% (-69.1 to -10.8); raloxifene, -9.6% (-38.8 to 19.6); paroxetine, -36.6% (-84.7 to 11.5). There were no significant differences in hot flash diary results between treatment groups.
Measures of hot flash frequency and severity show acceptable test/retest reliability between screening and baseline. Reductions in vasomotor symptoms by raloxifene are numerically less than those seen with placebo, but no statistically significant treatment differences have been documented in this small study. The large effect of placebo and the significant reduction in vasomotor symptoms by paroxetine are consistent with other studies. The diary seems to be suitable for use in hot flash clinical trials.
本试验对潮热事件发生时报告的日记进行检查，以评估日记的重测信度及其测量治疗对潮热频率和严重程度影响的能力。
42名绝经后女性（年龄≥40岁；每周潮热5 - 50次）被随机分为三组（3:3:1），分别每日服用安慰剂、60毫克雷洛昔芬或20毫克帕罗西汀，为期12周。潮热频率和严重程度的日记评估间隔为1周（研究治疗前两次，研究治疗期间三次）。
对41名女性进行了评估。各组间基线特征相似（例如，平均每周潮热29.8次）。筛查（第 - 2周）与基线（第 - 1周）时潮热频率和严重程度测量的一致性相关系数分别为0.73和0.71。12周后，每周潮热频率相对于基线的平均（95%CI）百分比变化如下：安慰剂组为 - 37.4%（- 60.9至 - 14.0）；雷洛昔芬组为 - 14.2%（- 37.7至9.3）；帕罗西汀组为 - 49.8%（- 88.6至 - 11.0）；潮热严重程度的平均（95%CI）百分比变化如下：安慰剂组为 - 39.9%（- 69.1至 - 10.8）；雷洛昔芬组为 - 9.6%（- 38.8至19.6）；帕罗西汀组为 - 36.6%（- 84.7至11.5）。各治疗组间潮热日记结果无显著差异。
潮热频率和严重程度的测量在筛查和基线之间显示出可接受的重测信度。雷洛昔芬对血管舒缩症状的减轻在数值上低于安慰剂组，但在这项小型研究中未记录到统计学上显著的治疗差异。安慰剂的显著效果以及帕罗西汀对血管舒缩症状的显著减轻与其他研究一致。该日记似乎适用于潮热临床试验。
