Pilot study of the efficacy and safety of a modified-release magnesium 250 mg tablet (Sincromag) for the treatment of premenstrual syndrome.
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 250 mg 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 > or =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.
Quaranta
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Unità Operativa Ostetricia e Ginecologia, Azienda Ospedaliera Ospedale San Carlo Borromeo, Milan, Italy.
Buscaglia
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MA
Meroni
M G
MG
Colombo
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E
Cella
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D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008274:Magnesium / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008275:Magnesium Deficiency / Q000150:complications / Q000188:drug therapy; D008875:Middle Aged; D010349:Patient Compliance; D010865:Pilot Projects; D011293:Premenstrual Syndrome / Q000150:complications / Q000188:drug therapy*; D013607:Tablets; D013997:Time Factors; D016896:Treatment Outcome; D014717:Vertigo / Q000139:chemically induced
D003692:Delayed-Action Preparations; D013607:Tablets; D008274:Magnesium