Abstract
ObjectiveTo 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.MethodsA 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.ResultsThere 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.ConclusionThe 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.
Highlights
The premenstrual syndrome (PMS) was first described in 1931 by Frank and Horney, who speculated on the possible physiopathological origins of the condition and on some forms of treatment [1]
One patient in Group A was excluded from the study due to hyperprolactinemia and one patient in Group B due to thyroid dysfunction
The results of the current study present some evidence in support of the use of essential fatty acids in PMS patients
Summary
The premenstrual syndrome (PMS) was first described in 1931 by Frank and Horney, who speculated on the possible physiopathological origins of the condition and on some forms of treatment [1]. PMS is understood as the set of somatic, affective, psychic and behavioral manifestations. There are women who experience some clinical signs and symptoms such as mastalgia and pain in their lower limbs, but who have none of the symptoms that cause psychic suffering. At the other extreme are the women who suffer from premenstrual dysphoric disorder (PMDD). According to the American Psychiatric Association, this is the term currently used to define the most severe forms of PMS that require psychiatric intervention due to the severity of the patient’s clinical condition, which may include deep depression and suicide/homicide attempts [4]. For a diagnosis of PMDD, a defined set of symptoms must be prospectively documented and shown to provoke significant functional disability [5]
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