Saffron (stigma of Crocus sativus L.) relieve symptoms of premenstrual syndrome (PMS): A clinical study
by Forest Raga December 15, 2020
The present study was carried out to investigate the efficacy and safety of Crocus sativus L. (saffron) in the treatment of the premenstrual syndrome.
Objective: The aim of this double€blind and placebo€controlled trial was to investigate whether saffron (stigma of Crocus sativus L.) could relieve symptoms of premenstrual syndrome (PMS).
Treatment Offered
Women aged 20€“45 years with regular menstrual cycles and experience of PMS symptoms for at least 6 months were eligible for the study.
Women were randomly assigned to receive capsule saffron 30 mg/day (15 mg twice a day; morning and evening) (group A) or capsule placebo (twice a day) for two menstrual cycles (cycles 3 and 4).
Main outcome measures The primary outcome measure was the Daily Symptom Report, and the secondary outcome measure was the Hamilton Depression Rating Scale.
Research Candidates
Seventy€eight women were screened for the study and 50 were randomized to trial medication (25 women in each group) (Figure€ƒ1). No significant differences was identified between women randomly assigned to the group A or B condition with regard to basic demographic data, including age, marital status and level of education (Table€ƒ1). Three women dropped out over the trial (one from the saffron and two from the placebo group) due to withdraw consent (they were convinced by their family that withdraw from the research project).
| Saffron group | Placebo group | P | |
|---|---|---|---|
| Age (mean ± SD) | 35.10 ± 7.79 (years) | 33.45 ± 7.61 (years) | NS |
| Marital status | Single: 20 | Single: 21 | NS |
| Married: 8 | Married: 7 | ||
| Divorced: 2 | Divorced: 2 | ||
| Level of education | Under diploma: 6 | Under diploma: 5 | NS |
| Diploma: 10 | Diploma: 10 | ||
| Higher diploma: 9 | Higher diploma: 10 |
Results
In this trial, saffron was found to be effective in relieving symptoms of PMS. A significant difference was observed in the efficacy of saffron in cycles 3 and 4 in the Total Premenstrual Daily Symptoms and Hamilton Depression Rating Scale.
The mean ± SD scores of two groups of women are shown in Figure€ƒ2. There were no significant differences between the two groups in month 2 (baseline, cycle 2) on the Total Daily Symptom Ratings (t = 0.69, df = 48, P = 0.48). The difference between the two protocols was significant as indicated by the effect of group, the between€subjects factor (Greenhouse€Geisser corrected: F = 11.13, df = 1, P = 0.002). A responded was defined as a woman showing 50% reduction in severity of symptoms. The number of responded was 19 (76%) in the saffron group and 2 (8%) in the placebo group (P < 0.0001; number needed to treat = 1.47). The behavior of the two treatment groups was not homogeneous across time (groups€by€time interaction, Greenhouse€Geisser corrected: F = 53.09, df = 1.55, P < 0.0001). In addition, a one€way repeated measures analysis of variance showed a significant effect of saffron on the Total Daily Symptom Ratings (P < 0.0001). In saffron group, post hoc comparisons showed a significant change from cycle 3. 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).
Figure 2
Mean ± SD scores of two groups of women on the Total Premenstrual Daily Symptoms scores. NS, non significant and ***P < 0.001. The horizontal symbols (***) were used to express statistical significance versus their respective baseline value and vertical symbols (
) were used for between€group comparisons.
Conclusion
The results of this study indicate the efficacy of C. sativus L. in the treatment of PMS.
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