Department of Maternal and Child Healthcare, School of Medicine, Federal University of Pernambuco, Recife, Pernambuco, Brazil.
Reprod Health. 2011 Jan 17;8:2. doi: 10.1186/1742-4755-8-2.
To evaluate the effectiveness and safety of polyunsaturated fatty acids for the treatment of the premenstrual syndrome (PMS) using a graded symptom scale and to assess the effect of this treatment on basal plasma levels of prolactin and total cholesterol.
A randomized, double-blind, placebo-controlled study was conducted with 120 women with PMS divided into three groups and treated with 1 or 2 grams of the medication or placebo. Symptoms were recorded over a 6-month period using the Prospective Record of the Impact and Severity of Menstruation (PRISM) calendar. Total cholesterol and prolactin levels were measured. Analysis of variance (ANOVA), Pearson's chi-square test, Wilcoxon's nonparametric signed-rank test for paired samples and the Mann-Whitney nonparametric test for independent samples were used in the statistical analysis.
There were no differences in age, marital status, schooling or ethnicity between the groups. In the group treated with 1 gram of the medication, a significant reduction was found when the median PRISM score recorded in the luteal phase at baseline (99) was compared with the median score recorded in the 3rd month (58) and in the 6th month of evaluation (35). In the 2-gram group, these differences were even more significant (baseline score: 98; 3rd month: 48; 6th month: 28). In the placebo group, there was a significant reduction at the 3rd but not at the 6th month (baseline: 96.5; 3rd month: 63.5; 6th month: 62). The difference between the phases of the menstrual cycle was greater in the 2-gram group compared to the group treated with 1 gram of the medication. There were no statistically significant differences in prolactin or total cholesterol levels between baseline values and those recorded after six months of treatment.
The difference between the groups using the medication and the placebo group with respect to the improvement in symptomatology appears to indicate the effectiveness of the drug. Improvement in symptoms was higher when the 2-gram dose was used. This medication was not associated with any changes in prolactin or total cholesterol levels in these women.
使用分级症状量表评估多不饱和脂肪酸治疗经前期综合征（PMS）的有效性和安全性，并评估该治疗对基础催乳素和总胆固醇血浆水平的影响。
采用随机、双盲、安慰剂对照研究，将 120 名 PMS 女性患者分为三组，分别给予 1 克或 2 克药物或安慰剂治疗。使用前瞻性记录月经影响和严重程度（PRISM）日历在 6 个月的时间内记录症状。测量总胆固醇和催乳素水平。统计分析采用方差分析（ANOVA）、皮尔逊卡方检验、配对样本的 Wilcoxon 非参数符号秩检验和独立样本的 Mann-Whitney 非参数检验。
各组间年龄、婚姻状况、教育程度和种族无差异。在接受 1 克药物治疗的组中，与基线时黄体期记录的 PRISM 中位数评分（99）相比，第 3 个月（58）和第 6 个月（35）的中位数评分显著降低。在 2 克组中，这些差异更为显著（基线评分：98；第 3 个月：48；第 6 个月：28）。在安慰剂组中，第 3 个月但第 6 个月无显著降低（基线：96.5；第 3 个月：63.5；第 6 个月：62）。与 1 克组相比，2 克组在月经周期各阶段的差异更大。治疗 6 个月后，催乳素或总胆固醇水平与基线值无统计学差异。
与安慰剂组相比，使用药物的组在症状改善方面的差异似乎表明了药物的有效性。使用 2 克剂量时，症状改善更为明显。该药物未导致这些女性催乳素或总胆固醇水平发生任何变化。
