Pilot study of the efficacy and safety of a modified-release magnesium 250 mg tablet (Sincromag) for the treatment of premenstrual syndrome

Clin Drug Investig. 2007;27(1):51-8. 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 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.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Delayed-Action Preparations / administration & dosage
  • Delayed-Action Preparations / adverse effects
  • Delayed-Action Preparations / therapeutic use*
  • Drug Administration Schedule
  • Female
  • Humans
  • Magnesium / administration & dosage
  • Magnesium / adverse effects
  • Magnesium / therapeutic use*
  • Magnesium Deficiency / complications
  • Magnesium Deficiency / drug therapy
  • Middle Aged
  • Patient Compliance
  • Pilot Projects
  • Premenstrual Syndrome / complications
  • Premenstrual Syndrome / drug therapy*
  • Tablets
  • Time Factors
  • Treatment Outcome
  • Vertigo / chemically induced


  • Delayed-Action Preparations
  • Tablets
  • Magnesium