A three months intake of soy lecithin phosphatidylserine/phosphatidic acid complex (PAS) and effects on the premenstrual syndrome (PMS)

INTERVENTION: Intervention 1: For 3 cycles: 4 capsules Soy lecithin phosphatidylserine/phosphatidic acid complex (PAS) per day, oral administration 3 times/day to the main meals (1‐1‐2) Ingredients per capsule: 100mg phosphatidylserine, 100mg phosphatidic acid, 235mg other phospholipids & glycerides, 5mg silicon dioxide Intervention 2: For 3 cycles: 4 placebo capsules per day, oral administration 3 times/day to the main meals (1‐1‐2) Ingredients per capsule: 435mg maze starch, 5mg silicon dioxide CONDITION: N94.3 ‐ Premenstrual tension syndrome Premenstrual Syndrome PRIMARY OUTCOME: Treatment effects of PAS compared to placebo on severity of PMS symptomatology using daily online DRSP (Daily Record of Severity of Problems) tool. The DRSP was developed by Endicott et al. (2006) to aid in the diagnosis and evaluation of PMDD / PMS according to DSM‐IV. It has been shown to be a reliable and valid measure of severity of problems concerning premenstrual symptoms. Several studies demonstrated a high test‐retest reliability and internal consistency of summary scores in women who ranged from few/no premenstrual problems to those meeting the criteria for PMDD (Endicott et al., 2006). Summary scores were also reported to be sensitive to change and treatment differences.The DRSP questionnaire comprises 24 items to assess the severity of problems on a daily basis. Subjects rate their severity on a six‐point rating scale ranging from 1 (not at all) to 6 (extreme). Psychological symptoms like depression, anxiousness, mood swings, irritability and difficulties in concentration but also physiological symptoms like breast tenderness, headache or weight gain are retrieved. The symptom diary has to be filled out every day in the evening to note the degree of the experienced problems. Within the study design the questionnaire will be completed every evening (5pm to 12am local time) online for 4 complete cycles in part A of the study (1 cycle baseline assessment, 3 cycles treatment assessment) and two additional complete cycles in part B of the study. Primary outcome of this study is the total score of this questionnaire acting as an objective indication of response to the therapy with PAS. The total score is calculated by summing up items 1a, 1b, 1c, 2, 3a, 3b, 4a, 4b, 5, 6, 7, 8a, 8b, 9a, 9b, 10a, 10b, 11a, 11b, 11c and 11d. INCLUSION CRITERIA: PMS diagnosis; Regular menstrual cycle with a constant cycle duration (25‐35 days); Easy access to computer and internet at home SECONDARY OUTCOME: Effects of PAS on depressive symptoms, physical symptoms, anger/irritability and within cycle increase in symptom severity using DRSP tool and on salivary cortisol.; The DRSP questionnaire comprises 24 items to assess the severity of problems on a daily basis. Subjects rate their severity on a six‐point rating scale ranging from 1 (not at all) to 6 (extreme). Psychological symptoms like depression, anxiousness, mood swings, irritability and difficulties in concentration but also physiological symptoms like breast tenderness, headache or weight gain are retrieved. The symptom diary has to be filled out every day in the evening to note the degree of the experienced problems. Within the study design the questionnaire will be completed every evening (5pm to 12am local time) online for 4 complete cycles in part A of the study (1 cycle baseline assessment, 3 cycles treatment assessment) and two additional complete cycles in part B of the study. The three subscales of the DRSP Depressive symptoms, Physical symptoms and Anger/irritability serve as secondary outcomes in this study. The Depressive symptoms subscore is calculated by summing up items 1a, 1b, 1c, 9a, 9b and 10a; the Physical symptoms subscore is calculated by summing up items 11a, 11b, 11c and 11d and the Anger/irritability subscore is calculated by summing up items 4a and 4b. ; In part A of this study salivary cortisol is assessed on days 8 and 9 of the individual menstrual cycle and days ‐4 and ‐3 of the individual menstruation at home (at awakening +0 min, +30 min, +45 min, +60 min and at 8pm) during the first and the last cycle.; Saliva samples are collected by using Salivette® Cortisol (Sarstedt, Nuembrecht, Germany).