Table 2. Characteristics of the studies included in the systematic review.
| Author | Country | Study type | Chief complaint | Sample size | Intervention group | Control group | Measure | Outcomes |
|---|---|---|---|---|---|---|---|---|
| Bahrami et al. [25] | Iran | RCT | - PMS | 897 | - Nine capsules containing 50,000 IU of vit D for 9 weeks | Without control group | - Serum [25(OH)D3] | - Reduced incidence of PMS: 10.1% |
| - Dysmenorrhea | - Individuals rated scale | - Reduced incidence of PMS and dysmenorrhea: 7% | ||||||
| - Reduced incidence of vit D deficiency: 6.1% | ||||||||
| Dadkhah et al. [26] | Iran | RCT | PMS | 86 | - A tablet containing 200 mg vit D daily for 2 months | Placebo | - Daily rating test | - Decreased incidence of PMS symptoms in vit D group from 37.4 to 25.5 and in vit E group from 38.4 to 22.8 |
| - 100 mg vit E daily for 2 months | ||||||||
| Ghanbari et al. [27] | Iran | RCT | PMS | 179 | - 500 mg of Ca carbonate twice daily for 3 months | Placebo | - Breast tenderness, fatigue, lack of energy, appetite changes, sleep problems, headache, depression, agitation, and irritability | - Dropped mean symptom scores from 7.2±3.8 to 6±3.6 in intervention group and from 6.5±3.6 to 5.8±3.8 in placebo group |
| - Beck test | ||||||||
| Karimi et al. [28] | Iran | RCT | PMS | 40 | - The CBT group (trained in weekly 45-minute sessions for 8 weeks; each week included 1 training session) | Control group | - PSST questionnaire | - Dropped mean PSST scores from 19±1.7 to 14.3±4.1 in CBT group, from 29±5 to 18.8±9.1 in Ca+vit D group, from 41.2±2.1 to 9.1±2.6 in group, Ca+vit D and CBT, and from 27.5±9.5 to 27.2±9.4 in control group |
| - The Ca+vit D group (with 500 mg of Ca and 200 IU of vit D, prescribed twice a day) | ||||||||
| - CBT+Ca+vit D group | ||||||||
| Kermani et al. [29] | Iran | RCT | PMS | 89 | - Combined Ca and vit E (1,000 mg of Ca and 400 units of vit E) | Placebo | - A questionnaire similar to premenstrual profile 2005 | - Decreased mean PMS symptoms from 20 to 9 in intervention group and from 20 to 14.3 in placebo group |
| Khajehei et al. [30] | Iran | RCT | PMS | 180 | - Tablet containing 5 mg of dydrogesterone | Placebo | - American Psychiatric Association standard diagnostic criteria for PMS | - Decreased mean PMS symptoms from 50.6 to 46 in vit D+Ca group, from 52.1 to 47.9 in dydrogesterone group, and from 53.7 to 50.3 in placebo group |
| - 500 mg of Ca+200 mg of vit D | ||||||||
| Mandana and Azar [31] | Iran | RCT | PMS | 155 | - 1 g of Ca during 7 final days of the cycle for 3 cycles | Placebo | - Rosignol Bonlender questionnaire | - Declined mean of social and physical symptoms in Ca group from 19.4±3.4 to 17.3±2.3, in vit E group from 19.4±19 to 16.2±3.4, in Omega-3 group from 19.1±2.3 to 17.1±3.4, in vit B6 group from 19.4±2.6 to 16.7±2.1, and in placebo group from 19.8±2.5 to 18.5±2.4 |
| - 100 mg of vit E daily for 3 cycles | ||||||||
| - 1 g of capsule of fish oil for 3 months | ||||||||
| - 40 mg of vit B6 daily for 3 months | ||||||||
| Samieipour et al. [32] | Iran | RCT | PMS | 210 | - Vit B1 (100 mg) | Placebo | - DMS-IV questionnaire | - Mean pain level in intervention group was 2.6±1.5 during the trial and 7.9±1 in the control. |
| - Ca carbonate (500 mg) | - Ca was more effective on general PMS symptoms than other treatments (P>0.05) | |||||||
| Samieipour et al. [33] | Iran | RCT | PMS | 264 | - Vit B1 (100 mg) daily, 4 days after menstruation for the 2 cycles | Placebo | - DSM-IV questionnaire | - Diminished mean of symptoms in B1 group from 61.2±30.5 to 45.9±13.3, in Ca group from 61.2±31.4 to 29.9±11.1, in Ca + B1 group from 62±30.5 to 25.3±16.8, and in placebo group from 61.5±30.5 to 53.9±18.3 |
| - Ca (500 mg) daily, 4 days after menstruation for the 2 cycles | ||||||||
| - Vit B1 plus Ca, daily, 4 days after menstruation for the 2 cycles | ||||||||
| Shehata [34] | Egypt | RCT | PMS | 210 | - COC pills (drospirenone 3 mg+ethinyl estradiol 0.03 mg) daily for 21 days starting from the third day of menstruation+oral placebo similar to Ca and vit D (daily) | Placebo similar to Ca and vit D+oral placebo similar to COC | - DRSP scores | - Dropped mean scores in Ca+vit D group from 56.9±14.7 to 25.1±9.1, in COC group from 60.6±15.6 to 18.7±6.4, and in placebo group from 61.5±15.7 to 35.2±13.2 |
| - Ca 400 mg+vit D 400 IU once daily+oral placebo similar to COC | ||||||||
| Shobeiri et al. [35] | Iran | RCT | PMS | 66 | - 500 mg of Ca daily for 2 cycles | Placebo | - DMS-IV | - Dropped mean scores in Ca group from 10.5±2.7 to 5.5±2.9, and in placebo group from 8.4±1.7 to 8.2±1.8 (after 2 cycles of intervention) |
| Shobeiri et al. [36] | Iran | RCT | PMS | 64 | - 500 mg of Ca daily for 2 cycles | Placebo | - DSM-IV questionnaire (headache, low back pain, depression, excitability, general pain, and abdominal pain) | - Reductions in the overall severity of physical PMS symptoms in intervention group from 155.9±22.9 to 136.4±19.3 during the first cycle and to 128.9±17.4 in the second cycle |
| Sutariya et al. [37] | India | RCT | PMS | 355 | - Ca carbonate or gluconate 500 mg 1 b.d. for 3 cycles | Health, nutrition, hygiene education | - 17 daily individual symptoms ratings (PMS diary) | - Lowered mean pain scores from 0.8±0.7 to 0.3±0.4 in intervention group, and from 0.6±0.6 to 0.4±0.5 in the control group at the end of the third cycle |
| Tartagni et al. [38] | Italy | RCT | PMS low serum [25(OH)D3] levels (≤10 ng/mL) | 158 | - Vit D supplementation (100,000 IU vit D3 vials) | Placebo | - Serum [25(OH)D3] | - Reduced anxiety score from 50 to 21 |
| - Parathyroid hormone | - Reduced excitability score from 130 to 70 | |||||||
| - Ca | - Reduced crying and anxiety points from 41 and 51 to 30 and 31, respectively | |||||||
| - Standard diagnostic criteria for PMS from ACOG | - Reduced disturbed relationships from 150 to 70 | |||||||
| Yonkers et al. [39] | New Haven, USA | RCT | PMS | 39 | - Fluoxetine (10 mg twice daily) | Placebo | - DSM-IV questionnaire | - 80% improvement in fluoxetine group |
| - Ca carbonate (600 mg twice daily) | - 42% improvement in Ca group | |||||||
| - 42% improvement in placebo group | ||||||||
| Akhlaghi et al. [40] | Iran | Clinical trial | PMS | 100 | - 1,000 mg of effervescent Ca per day in 5 days | Without control group | Utah PMS Calendar II questionnaire | - Decreased PMS psychological symptoms (62%) |
| - Reduced PMS physical symptoms (61%) | ||||||||
| Bharati [41] | India | Quasi-experimental | PMS | 58 | - Yoga group 45 minutes daily, 5 days a week, for 3 months (n=20) | Control group (n=18) | - ACOG diagnostic criteria | - Reductions in mean numbers of PMS symptoms from 5.8 to 3.9 in yoga group, from 5.3 to 4.3 in Ca group, and from 6 to 5.8 in the control group |
| - Ca group, oral tablets of Ca carbonate daily (500 mg, for 3 months) (n=20) | ||||||||
| Bertone-Johnson et al. [42] | Massachusetts, USA | Cross-sectional | PMS | 90 | - | PMS symptom severity of “none” or “mild” | - Serum [25(OH)D3] | - An inverse relationship between severity of PMS symptoms and intake of vit D (OR: 0.3) |
| - Questionnaire similar to those used by Mortola et al. [43] | ||||||||
| Obeidat et al. [44] | Jordan | Cross-sectional | - PMS | 177 | - | Without any intervention | - Plasma [25(OH)D3] level | - In cases of PMS, 91.8% presented hyperparathyroidism with 91.9% showing low levels, and 91% had insufficient amounts of vit D |
| - Primary dysmenorrhea | - Intact parathyroid hormone level | - In cases of PMS, 92.1% of patients consumed dairy products less than 2 meals | ||||||
| - Dairy products intake | ||||||||
| - Primary dysmenorrhea | ||||||||
| - 12 symptoms during the premenstrual phase | ||||||||
| Bahrami et al. [21] | Iran | Cross-sectional | - PMS | 897 | - | Without any intervention | - Serum [25(OH)D3] | - In cases of PMS, 359±46.9 of cases had vit D deficiency and 115±47.3 of subjects had Ca deficiency |
| - Dysmenorrhea | - Serum Ca | |||||||
| - Serum albumin | ||||||||
| - 16 items during the premenstrual phase | ||||||||
| - Self-administered questionnaire | ||||||||
| Pambudi [19] | Indonesia | Cross-sectional | PMS | 45 (case=33, control=12) | - | Women without PMS | - Ca serum levels | - The case group (90.9%) and the control group (25%) contained Ca levels ≤9.4 mg/dL |
| - Daily symptom checklist | - Cut-off point level of Ca for PMS incidence was 9.40 mg/dL | |||||||
| - The case group (9.1%) and the control group (75%) displayed Ca levels >9.4 mg/dL | ||||||||
| Abbasi et al. [45] | India | Case-control | PMS | 85 (case=43, control=42) | - | Healthy women | - Serum Mg | - Mean serum level of vit D was 14.2±2.3 ng/dL in the case group, and 26.2±4 ng/dL in the control group |
| - Serum [25(OH)D3] | - Serum magnesium levels averaged 1.7±0.3 and 1.8±0.1 mg/dL in the case and control groups, respectively | |||||||
| Bertone-Johnson et al. [22] | USA | Case-control | PMS | 3,025 (case=1,057, control=1,968) | - | No diagnosis of PMS and no or minimal menstrual symptoms | - Intake of Ca and vit D | - Total Ca intake values were 12.9±1,027 and 1,057±9.4 mg/dL in the case and control groups, respectively |
| - NHS2 questionnaire | - The overall vit D intake values were 390±7.6 and 401±5.6 IU/dL in the case and control groups, respectively (no significant difference, P>0.5) | |||||||
| Ghalwa et al. [46] | Palestine | Case-control | PMS | 120 (case=60, control=60) | - | Without any suspicion of PMS | - Serum Mg | - Moderate and severe PMS recorded in 26.2% and 2.4%, respectively, in cases of low serum Ca levels |
| - Serum Ca | - Moderate and severe PMS observed in 9.6% and 1.9%, respectively, in cases of low serum Mg levels | |||||||
| - Semi-quantitative food frequency questionnaire | ||||||||
| Rajaei et al. [20] | Iran | Case-control | PMS | 73 (case=41, control=32) | - | Women without PMS | - Serum levels of [25(OH)D3] | - Serum levels of [25(OH)D3] averaged 13.7±2.2 and 12.6±2.2 in the case and control groups, respectively, (no significant difference, P>0.5) |
| - PSST | ||||||||
| Saeedian Kia et al. [47] | Iran | Case-control | PMS | 62 (case=31, control=31) | - | Women without PMS | - Serum Ca level | - Serum levels of [25(OH)D3] averaged 6.8±4 and 6.6±3.7 in the case and control groups, respectively |
| - Serum Mg level | - Mean Ca levels were 9.4±0.4 and 9.5±0.3 in the case and control groups, respectively | |||||||
| - Serum [25(OH)D3] level | - Mean Mg levels were 1.8±0.2 and 1.9±0.2 in the case and control groups, respectively | |||||||
| - Utah PMS Calendar II | ||||||||
| Sharma and Tandon [16] | India | Case-control | PMS | 50 (case=25, control=25) | - | Women without PMS | - Serum Ca level | - Luteal phase reductions of serum Ca levels in PMS patients compared to control group (Chi-square: 4.9) |
| - Serum Mg level | ||||||||
| - Self designed questionnaire | ||||||||
| Bertone-Johnson et al. [48] | USA | Case-control | PMS | 802 (case=401, control=401) | - | No PMS | - Serum [25(OH)D3] | - Mean serum levels of [25(OH)D3] were 66.5±20.5 and 64.8±19.9 nmol/L in the case and control groups, respectively |
| - Total Ca | - Mean Ca levels (mg/dL) were 9.7±0.3 and 9.7±0.3 in the case and control groups, respectively | |||||||
| - Intact parathyroid hormone | - Parathyroid hormone levels (pg/mL) averaged 31.2±11.2 and 31.6±11.6 in the case and control groups, respectively (no significant difference, P>0.05) | |||||||
| - NHS2 questionnaire |
PMS, premenstrual syndrome; COC, combined oral contraceptive; ACOG, The American College of Obstetricians and Gynecologists; Ca, calcium; Mg, magnesium; vit, vitamin; [25(OH)D3], 25-hydroxyvitamin D3; RCT, randomized controlled trial; PSST, premenstrual syndrome screening test; CBT, cognitive behavioral therapy; DMS-IV, Diagnostic and Statistical Manual of Mental Disorders, 4th edition; b.d., twice a day; DRSP, daily record of severity of problems; OR, odds ratio; NHS2, Nurses' Health Study II.