Table1.
Characteristics of 18 randomized controlled trials included in systematic review.
| Outcome(s) | Adverse effects | blinding method | Tool s |
Dropouts
(%) |
Baseline comparability | Participants control | Participants Intervention | Type of control | Intervention mg | Age (/Y) | Duration, (wk.) | Design | Author, Year | No |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Significant decrease in average mastalgia was observed between Chamomile Extract and MA-users in pre and post intervention after first and second cycles. However, no significant difference in average MAPMS symptoms was observed between chamomile Extract-users after first and second cycles Intra group difference(Wilcoxon test) p<0.0001 |
menstrual bleeding in nine (20%) of chamomile GI complication in (28.9%) of MA |
Double blind | Daily form of MAPMS (Mastalgia intensity Associated with PMS) | 26% | Yes | N=45 | N=45 | Mefenamic Acid 250 mg | Chamomile capsule 100 mg | 18 to 35 | 4 | RCT | Sharifi et al. (2014), Iran | 1 |
| Saffron was found to be effective in relieving Symptoms of PMS. A significant difference between cycles 3 and 4 was observed in the saffron group (p<0.001). The difference between the two protocols was significant at the endpoint (cycle 4) (t=5.92, df = 48, p<0.001) in the Total Premenstrual Daily Symptoms A significant difference between cycles 3 and 4 was observed in the saffron group (p<0.001). The difference between the two protocols was significant at the endpoint (cycle 4) (t=8.99, df = 48, p<0.001) in Hamilton Depression Rating Scale Rating Scale |
Appetite changes, Headache, Sedation, Nausea, Hypomania (None of adverse effects were severe) |
Double-blind | Daily Symptom Report for PMS Hamilton Depression Rating Scale |
6% | Yes | N=23 |
N=24 | placebo capsule | Saffron capsule 30 mg | 20 to 45 | 8 | RCT | Agha-Hosseini et al. (2007), Iran | 2 |
| In total, intervention and control groups had significant differences in terms of changes in the mean severity of PMS over time (p<0.001). | increased appetite, loss of appetite, sedation, nausea, headache, and euphoria | triple-blind | the simultaneous determination of stress, anxiousness, and depression scale (DASS21) shortened premenstrual assessment form (SPAF) |
11% | Yes | N=39 | N=39 | Placebo capsules | saffron capsules, 30-mg | 18 to 35 | 8 | RCT | Pirdadeh Beiranvand et al. (2015), Iran | 3 |
| After intervention total PMS score in curcumin group significantly decreased from 102.06±39.64 to 42.47±16.37 (mean Difference=49.13, 95% CI: 32.48 to 65.78; p<0.0001 ) Whereas this score after intervention in placebo group had not significant difference with before intervention (106.06±44.12 to 91.60±43.56). (mean Difference= 45.14, 95% CI: 27.71 to 62.55; , p=0.058 ) |
There was no side effects | double-blinded | daily record questionnaire for PMS | 10% | Yes | N=31 | N=32 | Placebo capsules | Curcumin oral gelatin capsules 100 mg |
premenopausal | 12 | RCT | Khayat et al. (2015), Iran | 4 |
| Intervention group revealed a significant reduction (p<0.001) in PMS symptoms and also the mean score of PMS intensity reduced at the three consecutive months after the intervention (p=0.001). | Not mentioned | double-blinded | General Health Questionnaire Premenstrual Syndrome Screening Tool (PSST). |
0% | Yes | n = 50 | n = 50 | placebo capsule | Melissa officinalis capsule 1200 mg | 16 high school |
12 | RCT | Akbarzadeh et al. (2015), Iran | 5 |
| The mean reduction in severity of PMS score was 6.79 in intervention, and 8.82 in placebo group which did not show any significant difference between the groups (p=0.157). Although Wilcoxon test showed that the severity of PMS score reduced significantly in both groups after the intervention. (In intervention group: Z=3.58, p=0.0001; in placebo group: Z=4.2, p=0.0001) The frequency of reported symptom score decreased from 84.13 in the first menstrual cycle to 56.5 in the fourth cycle in intervention group but this decrease was not significantly different in intervention and placebo groups |
Not mentioned | double-blinded | prospective record of the impact and severity of menstrual symptoms (PRISM) calendar | 14% | Yes | N=37 | N=38 | placebo pill | Zataria Pill, 80 mg | 18 to 35 | 8 | RCT | Sodouri et al. (2013), Iran | 6 |
| Wheat germ significantly reduced physical symptoms (63.56%), psychological symptoms (66.30%), and the general score (64.99%). Although the severity of symptoms decreased in both groups, this reduction was more significant in intervention group (p<0.001). On the other hand, physical symptoms decreased only in the intervention (p<0.001) and there was no statistically significant difference in the placebo group. | digestive complications (3 people) Complications were not reported in 95.2% of the wheat germ extract group and 92.9% of the placebo group. |
triple-blind | Beck Depression Inventory (BDI) Daily Symptom Record (DSR) |
16% | Yes | N=47 | N=37 | Placebo | capsules of wheat germ extract 400 mg |
20 to 45 |
8 | RCT | Ataollahi et al. (2015), Iran | 7 |
| Most of the PMS VAS scores were dropped in both groups, however it was more significant in the Vitex agnus group (p<0.0001). Mean Rank of differences of the headache, nervousness, restlessness, depression, breast pain and swelling, swelling and tympani had significantly difference, before and after the study, in both groups and between two groups (p<0.0001). |
There was no side effects | double-blind | Penn daily symptom report self-assessment with visual analogue scale (VAS) |
0% | Yes | N=66 | N=62 | 40 drops of placebo | 40 drops of Vitex agnus | child bearing age | 24 | RCT | Zamani et al. (2012), Iran | 8 |
| There was not a significant difference in the severity of premenstrual syndrome between the E. platyloba and placebo group before the intervention (100.8±22.1 vs. 104.3±19.5). With a significant difference was found between two groups after the intervention [(49.7±23.2 vs. 79.1±28.1), p=0.002]. |
unpleasant taste, nausea and vomiting | single blind | Daily Record of Severity of Problems form (DRSP) | 0% | Yes | N=30 | N=30 | Placebo, 30 drops | Echinophora platyloba extract 30 drops | 18 to 25 |
8 | RCT | Delaram M. (2014), Iran | 9 |
| All the symptoms showed a significantly greater improvement with the fennel extract than placebo (p<0.05) except bloating which was unaffected by the treatment. | Visual symptoms in 1 person of intervention, Allergic reactions, Gastric upset, Respiratory symptoms in 3 persons of placebo | double-blind | Daily Record of Severity of Problem Questionnaire (DRSP-Q) |
0% | No | n = 30 | n = 30 | placebo | 30 drops of fennel extract | Women ??? |
12 | RCT | Delaram and Heydarnejad. (2011), Iran | 10 |
| A significant difference was observed in mean premenstrual mood (p<0.001) and behavioral (p<0.001) symptoms severity of in the intervention group before and after the intervention the difference in mean of mood and behavioral symptoms before the intervention, and one, two, and three months after the intervention in the intervention group was significant (p<0.001). | There was no side effects | Double-blind | provisional diagnosis Form of PMS Day marks registration form |
0% | Yes | N=50 | N=50 | placebo | valerian pills | 18 to 35 | 12 | RCT | Behboodi Moghadam et al. (2014), Iran | 11 |
| The severity of Symptoms after treatment in both groups significantly decreased (p<0.001) But the severity of symptoms reduction significantly was higher by citrus essence | There was no side effects | Double-blind | Daily registration Symptoms form | 0% | Yes | N=40 | N=40 | 10 drops placebo | 10 drops of Citrus aurantiun | 18 to 35 | 8 | RCT | Ozgoli et al. (2012), Iran | 12 |
| The rate of decrease in Severity of PMS Symptoms after taking hypericum perforatum were 46.45% and 18.1% in placebo and there are Significant differences between the two groups in rate of PMS Symptoms reduction(p=0/000) | There was no side effects | Double-blind | Registration form of temporary status of premenstrual syndrome | 5% | Yes | N=31 | N=35 | placebo | 60 drops of hypericum perforatum | female Students ??? |
8 | RCT | Pakgohar et al. (2005) | 13 |
| Ginger could reduce The overall intensity of PMS and severity of mood, physical and behavioral symptoms significantly (p<0.001) | There was no side effects | Double-blind | temporary diagnosis form of PMS Daily symptom registration form |
5% | Yes | N=33 | N=33 | Placebo capsules | 250 mg Ginger capsules | 18 to 35 |
12 | RCT | Khaiat et al. (2014), Iran | 14 |
| The results showed a reduction of symptoms in treatment group comparing to the placebo. So that the mean severity was reported 23.64 in the Perforan group, and 46.37with (p=0.001) in the placebo group. | There was no side effects | double blinded | temporary diagnosis form of PMS | 7% | Yes | N=45 | N=48 |
placebo | Perforan 480 mg |
18 to 35 |
12 | RCT | KHeirkhah et al. (2013), Iran | 15 |
| The severity of psychological, physical, behavioral and overall symptoms of premenstrual syndrome 1-2 months after taking intervention in the valerian group was significantly lower than the control group (p<0.001) | Not mentioned | double blinded | Demographic and menstrual history Dickerson questionnaire |
0% | Yes | N=60 | N=60 | placebo capsules | Valerian Officinalis capsules 530 mg | female students ??? |
8 | RCT | Kamranpour et al. (2015), Iran | 16 |
| The mean scores of PMS physical symptoms (p<0.001) , Psychological symptoms (p<0.05) and PMS duration (p<0.01) Between two groups had a significant difference during the second and third cycle | Not mentioned | double blinded | Rossignol standard questionnaire Recorded daily symptoms of menstruation |
15% | Yes | N=31 | N=30 | placebo | Vitagnus , 44 drops | female students ??? |
12 | RCT | Mousavi et al. (2014), Iran | 17 |
| The PMS improved significantly in both intervention groups during the first and the second month after the intervention. In the Vitexagnus and Flaxseed groups, the mean total PMS score were significantly lower than that in the control group at the first months. In the second month There was no significant difference between the Vitexagnus and Flaxseed groups in terms of the PMS score. In comparison of Flaxseed and Vitexagnus groups after intervention ( mean difference = -0.1; 95% CI:-2.4-0.3; p=0.187) |
In flaxseed Group diarrhea (2 cases) In vita gnus Group nausea (1 cases) |
triple-blind | The Shortened Premenstrual Assessment Form: PAF | 1% | Yes | N=52 | N=52 N=53 |
The third group placebo of vitagnus and Package containing 25 grams of wheat flour | Flax seed powder25 g daily Plus placebo pills ofVitex agnus castus Vitex agnus castus pills Plus placebo of flaxseed |
18 to 45 |
8 | RCT | Mirghafourvand et al. (2015), Iran | 18 |