TABLE 4.
Author, year, study design | Study purpose | Study population | Intervention | Outcome data | Conclusions | Limitations of findings |
---|---|---|---|---|---|---|
Muneyyirci-Delale et al year: 2013study design: RCTcountry: USAfunding source: unknownquality grade: positive (+) | To evaluate the effect of spironolactone, glucophage and magnesium on serum lipid profile, FFA concentrations and insulin sensitivity among women with PCOS | Premenopausal American women (n = 36)Aged: 18–42 yRecruitment: outpatient OBGYN clinicDx of PCOS: Rotterdam criteria | Group 1 (n = 14) 500 mg glucophage twice daily; Group 2 (n = 10) 400 mg magnesium oxide by mouth, twice daily; Group 3 (n = 12) 50 mg spironolactone twice daily x 12 wk. A glucose tolerance test with 75 g glucose load was performed at baseline and after treatment, collecting blood at 0, 1, and 2 h for insulin, glucose, FFA, and aldosterone. Subjects were asked not to change dietary habits or physical activity | - Mg supplementation did not significantly change weight, cholesterol, FFA, or insulin sensitivity. - The glucophage group significantly decreased BMI (33.3 ± 1.95 kg/m2 to 32.79 ± 1.95 kg/m2, P = 0.04). - The spironolactone group significantly decreased systolic blood pressure (P =0.04) and FFA concentrations (P < 0.03) with posttreatment basal aldosterone concentrations significantly increased (P < 0.001) |
While Mg supplementation did not result in significant improvements in the outcomes, supplementation may still be beneficial in the treatment of PCOS. However, future studies evaluating higher doses, longer durations, and potentially different preparations of magnesium are needed | -Very small sample size. - Lack of blinding. - Limited demographics described. - Lack of controls to assess FFA and aldosterone concentrations. - Only 20% of women in the study were anovulatory. - Phenotype not evaluated |
Jamilian M et al year: 2017study design: RCTcountry: Iranfunding source: Grant from the Vice-chancellor for Research, AUMS, and Iran quality grade: positive (+) | To investigate the effects of Mg, Zn, Ca, and vitamin D supplementation on glycemic control and cardiometabolic risk markers among women with PCOS | Premenopausal Iranian women (n = 60)Aged: 18–40 yRecruitment: referral to the Research and Clinical Center for Infertility at the Kosar clinicDx of PCOS: Rotterdam criteria | Subjects were matched for BMI, age, and phenotypes of PCOS and then were randomly assigned into 2 groups to receive100 mg Mg, 4 mg Zn, 400 mg Ca plus 200 IU vitamin D (n = 30) or placebo (n = 30) twice daily x 12 wk. All consumed metformin tablet at the initial dose of 500 mg, which was increased in increments of 500 mg to 1500 mg/d x first 3 wk. All were advised to maintain their routine habits, 3-d food records and 3 physical activity records at weeks 0, 3, 6, 9, and 12 | Supplement vs. placebo: - Significantly increased serum Mg (+0.1 ± 0.1 vs. −0.1 ± 0.3 mg/dL, P = 0.002). - Significant decreased serum insulin concentrations (–1.9 ± 4.6 vs. +0.4 ± 2.8μIU/mL, P = 0.01), and HOMA-IR (-0.4 ± 1.0 vs. +0.1 ± 0.6, P = 0.02). - Significantly increased QUICKI (+0.01 ± 0.02 vs. −0.0003 ± 0.01, P = 0.02). - Significant difference in baseline FPG (P = 0.03), Mg (P < 0.001) and Ca (0.005). - Postadjustment of baseline variables, insulin (P = 0.10), HOMA-IR (P = 0.08) and QUICKI (P = 0.08) between groups were no longer significant |
Mg-Zn-Ca-vitamin D cosupplementation over 12 wk may have a beneficial effect on insulin metabolism and cardiometabolic risk, however, further investigation with comparisons of similar baseline controls are needed to confirm results | - Need for single supplementation of each compared with cosupplementation.- Baseline values of biochemical variables between placebo and intervention group significantly different. - Relatively small amount of Mg supplemented (100 mg/d). - Limited demographics described |
Jamilian M et al year: 2019study design: RCTcountry: Iranfunding source: Grant from the Vice-chancellor for Research, AUMS, and Iranquality grade: Positive (+) | To investigate the effect of Mg and vitamin E cosupplementation on metabolic profiles of women with PCOS | Premenopausal Iranian women (n = 60)Aged: 18–40 yRecruitment: patients of the Clinical Center for Infertility at the Kossar clinicDx of PCOS: Rotterdam criteria | Subjects were randomly selected into 2 groups via computer; intervention 250 mg/d Mg plus 400 mg/d vitamin E (n = 30) or placebo (n = 30) x 12 wk. All participantscompleted 3-day food records and 3 physical activity records at weeks 0, 3, 6, 9, and 12 | Adjusted values supplementation vs. placebo: - Significantly reduced serum insulin concentrations (-1.0 ± 0.5 vs. 1.5 ± 0.5 μIU/mL, P = 0.002) and HOMA-IR (-0.2 ± 0.1 vs. 0.4 ± 0.1, P = 0.001). - Significantly increased QUICKI (0.003 ± 0.003 vs. −0.008 ± 0.003, P = 0.002). - Both groups were below the recommended Mg concentration of 2.07 mg/dL at baseline. - Posttrial, the cosupplementation group had serum Mg concentrations at 2.14 ± 0.8 mg/dL with a total change of (+0.09 ± 0.14) |
Mg and vitamin E cosupplementation over 12 wk among women with PCOS improves insulin metabolism but does not affect FPG concentrations | - Short duration. - Small sample size. - Need for single supplementation of each compared with cosupplementation. - Limited demographics described |
Ca, calcium; Dx, diagnosis; FFA, free fatty acid; FPG, fasting plasma glucose; Mg, magnesium; OBGYN, obstetrics and gynecology; PCOS, polycystic ovary syndrome; QUACKI, quantitative insulin sensitivity check index; RCT, randomized controlled trial; Zn, zinc.