Table 2.
Author | Study Design | Condition | Sample (N) | Age (year) | Treatment (s) | Control | Duration | Outcome Measure | Results | Effect Summary |
---|---|---|---|---|---|---|---|---|---|---|
Facchinetti et al. [88] | RCT Cross Placebo Cross | Premenstrual symptom complaints Moos Menstrual Distress Questionnaire (2 consecutive cycles (DSM-IIIR criteria)) | N = 28 | Placebo: x = 31.6 (SD = 5.9; 24–39); Treatment: x = 32.4 (SD = 6.2; 24–39) | Mg 360 mg as Mg pyrrolidone carboxylic acid | Placebo | 2 months baseline + 4 menstrual cycles. Treatment: Mg x 2 2 cycles; placebo: placebo x 2 cycles + Mg x 2 cycles (intake during luteal phases only) | Moos Menstrual Distress Questionnaire (8 symptom categories: pain, inability to concentrate, autonomic reactions, water retention, negative affect, arousal, total score). | Mg significantly reduced negative affect ratings in the placebo crossover group (x = 0.51 (SD = 0.45)) vs. placebo intake (x = 0.76 (SD = 0.70); p < 0.05) & in the Mg treatment group after 2 (x = 0.44 (SD = 0.47)) & 4 (x = 0.45 (SD = 0.46)) cycles vs. baseline (p < 0.02). | + |
Walker et al. [89] | R-Cross | Premenstrual symptom complaints Menstrual Health Questionnaire (MHQ; retrospective assessment of symptoms during last cycle) | N = 38 | 18–50 (71%–18–25; 7.9%–26–34; 13.2%–35–41; 7.9%–45–50) | Mg 200 mg as Mg oxide | Placebo (cellulose) | 4 menstrual cycles (2 cycles per treatment) | 22 item ordinal daily menstrual symptom diary (6 symptom categories: anxiety; cravings; hydration, depression, other, total) | No significant effect of treatment on anxiety related premenstrual syndrome symptoms. | x |
De Souza et al. [67] | R-Cross | Premenstrual symptom complaints Menstrual Health Questionnaire (MHQ; retrospective assessment of previous month and baseline) | N = 44 | x = 32 | (i) Mg 200 mg; (ii) vit B6 50 mg; (iii) Mg 200 mg + vit B6 50 mg (as Mg oxide) | Placebo | 5 consecutive menstrual cycles | 30 item ordinal daily menstrual symptom diary (6 symptom categories: anxiety; cravings; hydration, depression, other, total) | No overall treatment effect. Predefined factorial treatment contrasts of adjusted mean scores showed a significant effect of Mg 200 mg + vit B6 50 mg (x = 16.3) for reducing anxiety related premenstrual symptoms vs. baseline (x = 29.3) & placebo (x = 19.8; p = 0.04) for one menstrual cycle. | + 1 |
Walker et al. [64] | R-Cross | Premenstrual symptom complaints Menstrual Health Questionnaire (MHQ; retrospective assessment of previous month and baseline) | N = 85 | x = 35 | (i) Mg 200 mg; (ii) Mg 350 mg; (iii) Mg 500 mg (all as Mg oxide) | Placebo (sorbitol 1305 mg) | 2 menstrual cycles per condition | 20 item ordinal daily menstrual symptom diary (6 symptom categories: anxiety; cravings; hydration, depression, other, total) | Significant reduction in anxiety-related premenstrual symptoms after 2 months placebo (sorbitol) intake (x = 1.7 (SD = 2)) vs. 200 mg (x = 3.6 (SD = 2)), 350 mg (x = 2.8 (SD = 2)) & 500 mg (x = 3.2 (SD = 2)) Mg treatments. | x |
Khine et al. [63] | P Post-hoc R-Cross | Premenstrual complaints / Premenstrual Dysphoric Disorder (PMDD) Daily premenstrual symptoms VAS (3 months) & retrospective DSM-IV criteria for PMDD | N = 31 (PMDD n = 17; Placebo n = 14) | Control: x = 28.6 (SD = 6.4; 20–43); PMDD: x = 37.4 (SD = 4.4; 20–43) | Mg sulphate intravenous infusion 0.1mmol/kg body mass (4 h) | Premenstrual complaint-free controls | 24 h post infusion | Spielberger State-Trait Anxiety Inventory Premenstrual Tension Scale (Subjective & Objective) 100 mm premenstrual symptom VAS | No significant mood changes in controls. Evidence of improved VAS mood ratings in initial 6 PMDD women after Mg infusion resulted in post hoc initiated RCT-cross with remaining 10 PMDD women receiving Mg & placebo infusion. Mg infusion subsequently demonstrated to have no mood improvement effects above placebo. | x |
Quaranta et al. [85] | NR-Cross | Premenstrual symptom complaints Moos Modified Menstrual Distress Questionnaire (baseline score ≥ 25) | N = 38 | x = 32.6 (SD = 8.0; 18–45) | Mg 250 mg (Mg form unknown) | None | 3 menstrual cycles | Moos Modified Premenstrual Distress Questionnaire (including symptom categories: nervous tension, mood swings, irritability, anxiety). Monthly subjective PMS symptom diary | Moos Modified Menstrual Distress Questionnaire: Total score: Significant reduction after 3 months (x = 19.7 (SD = 7.6)) vs. screening visit (x = 30.5 (SD = 4.5); p < 0.001). Monthly subjective PMS symptom diary: Total score: Significant reduction at month 1 (x = 23.3 (SD = 10.6)), month 2 (x = 19.6 (SD = 7.8)), & month 3 (x = 17.9 (SD = 7.3)) with treatment vs. baseline months 1 (x = 31.8 (SD = 6.4)) & 2 (x = 31.3 (SD = 8.4); p < 0.001). PMS anxiety subscale: Significant decrease in anxiety subscale ratings at month 1 (x = 6.3), month 2 (x = 5.3), & month 3 (x = 5.0) with treatment vs. baseline (x = 8.4; p < 0.001). | + |
Fathizadeh et al. [87] | RCT | Premenstrual symptom complaints Daily premenstrual symptoms record (2 months) | N= 116 (Treatments (i) n = 38; (ii) n = 41; Placebo n = 37) | Placebo: x = 28.03; Treatment (i): x = 28.71; Treatment; (ii): x = 30.02 (all 15–45) | (i) Mg 250 mg; (ii) Mg 250 mg + vit B6 40 mg (Mg form unknown) | Placebo | 2 months | Daily menstrual symptom diary (6 symptom categories: anxiety, cravings, hydration, depression, somatic, total) | Significant reduction in total PMS symptoms in all conditions. Mg + vit B6 resulted in greatest reduction (p < 0.05). Significant main effect of treatments on change from baseline anxiety ratings (Mg + vit B6: x = −22.61 (SD= 20.36); Mg: x = −12.14 (SD = 26.14); placebo: x = 0 (SD = 20.41); p < 0.001). However, no between treatment planned contrasts or post-hoc tests reported. | +? |
1 Post hoc analyses; Mg—Magnesium; mg—milligrams; PMDD—Premenstrual Dysphoric Disorder; PMS—premenstrual syndrome; VAS—visual analogue scale; MHQ—Menstrual Health Questionnaire; + positive treatment effect; x no treatment effect; ?—doubts about outcome; RCT—randomised controlled trial; P—parallel groups; R-Cross—randomised crossover; NR-Cross—non-randomised crossover; B6—vitamin B6; SD—standard deviation.