Pilot Study of the Efficacy and Safety of a Modified-Release Magnesium 250mg Tablet (Sincromag??) for the Treatment of Premenstrual Syndrome

• Published in: Clinical drug investigation Vol. 27; no. 1; pp. 51 - 58
• Main Authors: Quaranta, S, Buscaglia, M.A, Meroni, M.G, Colombo, E, Cella, S
• Format: Journal Article
• Language: English
• Published: Wolters Kluwer Health, Inc 01-01-2007
• ISSN: 1173-2563
• DOI: 10.2165/00044011-200727010-00004

Background: Magnesium deficiency has been implicated as a possible contributing factor to some symptoms of premenstrual syndrome (PMS) and several studies have reported a lower intracellular magnesium concentration in women with PMS. Thus, it has been suggested that magnesium supplementation may improve certain symptoms in women with PMS. Objective: This open-label study assessed the efficacy and safety of a patented modified-release magnesium 250mg tablet for improving symptoms in women affected by PMS. Methods: After a 3-month observational period, women aged 18-45 years with a regular menstrual cycle (from 25-35 days) who were affected by PMS (determined by a score of ≥25 points on a PMS questionnaire) [n = 41] were given the modified-release magnesium tablet over three menstrual cycles, beginning 20 days after the start of their last menstrual period and continuing until the start of their next menstrual period. Results: PMS symptoms improved during magnesium treatment. After 3 months, the mean total PMS score (primary endpoint), as assessed by the investigator using Moos' Modified Menstrual Distress Questionnaire, was significantly lower than before therapy (p < 0.0001). During the same period, the mean PMS scores, as recorded in patients' diaries (secondary efficacy variables), also showed significant improvements (p < 0.0001 for all subscales). The relative decreases in total PMS scores, as assessed by investigator and patient, were 35.1% and 33.5%, respectively. The magnesium tablet was well tolerated, with vertigo the only treatment-related adverse event reported (one patient). Conclusions: We concluded that modified-release magnesium was effective in reducing premenstrual symptoms in women with PMS in this preliminary study.