Effectiveness of a Saffron and Withania Supplement on Mood in Women With Mild-to-Moderate Anxiety During the COVID-19 Lockdown.
Cristina Pages-García,
M Cristina De Almagro,
Jorge Ruiz-Moreno,
Roser De Castellar
Other
Depression and anxiety
2024
1 件の引用
PubMed
DOI
CC-BY
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Study Design
- 研究タイプ
- open-label prospective trial
- 介入
- Effectiveness of a Saffron and Withania Supplement on Mood in Women With Mild-to-Moderate Anxiety During the COVID-19 Lockdown. Saffron + Ashwagandha + Tryptophan + Vitamin B6 combination supplement (dose not specified)
- 比較対照
- Placebo
- 効果の方向
- Positive
- バイアスリスク
- High
Abstract
Background: A nutritional supplement based on medicinal plants (saffron and ashwagandha), tryptophan, and vitamin B6 could contribute to alleviating/improving mood and associated disorders. The aim of this study was to evaluate the potential benefits of this combination supplement. During the study period, participants underwent a period of forced home confinement due to the COVID-19 pandemic, which represented an unexpected impact factor. Methods: This open-label prospective trial enrolled a cohort of female employees who reported mild to moderate anxiety. The primary objective was to evaluate changes in the level of anxiety using the adapted Hamilton Anxiety Rating Scale (HARS) after 12 weeks of regular supplementation with Safromotive (two tablets daily, for 12 weeks). The secondary objectives were to evaluate health-related quality of life (HRQoL) and tolerability. Results: In total, 46 women with a mean age of 45.0 (6.5) years were included. A statistically significant improvement in HARS was observed, with a 7.5-unit decrease from baseline to 12 weeks (p < 0.0001) and from 4 to 12 weeks of supplement intake (p=0.0058). However, no significant changes were found during the lockdown period (between weeks 8 and 12 of the study). No relationship was found between women's sociodemographic characteristics and the HARS total score. A significant reduction in the HRQoL questionnaire score of 1.2 units was observed between baselines and 12 weeks of treatment (p=0.0273). At the end of the study, 78.6% of the women reported consistency the supplement intake during the study course. Conclusion: This nutritional supplement composed of saffron, ashwagandha, tryptophan, and vitamin B6 appears to improve anxiety and HRQoL, but confinement could have impacted the evolution of the outcome.
Full Text
Figures
Figure 1
Study design and participant flow for the trial evaluating a saffron and Withania (ashwagandha) supplement on mood in women with mild-to-moderate anxiety during the COVID-19 lockdown.
flowchart
Figure 2
Mood and anxiety score trajectories comparing the saffron-ashwagandha supplement group with control over the study period, suggesting improvements in emotional well-being.
chartTables
Table 1
| Characteristic |
|
|---|---|
| Sociodemographic data | |
| Age (years), mean (SD) | 44.96 (6.49) |
| Education, | |
| Higher | 33 (71.7) |
| Secondary | 13 (28.3) |
| Family composition, | |
| Couple with children | 24 (52.2) |
| Couple without children | 10 (21.7) |
| Alone with children | 7 (15.2) |
| Alone | 4 (8.7) |
| Other composition | 1 (2.2) |
| Employment status, | |
| Salaried | 45 (97.8) |
| Self-employed | 1 (2.2) |
| Anthropometrics | |
| Weight (kg), mean (SD) | 64.0 (10.9) |
| Height (cm), mean (SD) | 165.9 (5.9) |
| Healthy lifestyles, | |
| Regular physical activitya | 30 (65.2) |
| Sufficient vegetable consumptionb | 30 (65.2) |
| Nonsmokersc | 40 (86.9) |
| Low alcohol consumptiond | 46 (100.0) |
| Pathological history, | |
| Obesity | 1 (2.2) |
| Arthropathies | 2 (4.4) |
| Depression | 2 (4.4) |
| Respiratory disease | 2 (4.4) |
| Other | 3 (8.3) |
Table 2
| Time intervals |
| Change (%) | CI 95% |
|
|---|---|---|---|---|
| Hamilton Anxiety Rating Scale (global) | ||||
| 12 weeks—baseline | 28 | −46.61a | −60.93, −32.30 | <0.0001 |
| 12 weeks–4 weeks | 27 | −26.09a | −44.42, −7.75 | 0.0071 |
| 12 weeks–8 weeks | 27 | −13.84 | −33.16, 5.48 | 0.1529 |
| 8 weeks–4 weeks | 28 | −13.11 | −32.40, 6.17 | 0.1744 |
| 4 weeks—baseline | 37 | −22.39a | −33.60, −11.19 | 0.0003 |
| Hamilton anxiety rating—psychic subscale | ||||
| 12 weeks—baseline | 28 | −45.30a | −65.75, −24.85 | <0.0001 |
| 12–4 weeks | 28 | −25.69a | −42.67, −8.72 | 0.0045 |
| 12–8 weeks | 27 | −10.67 | −29.92, 8.56 | 0.2644 |
| 8–4 weeks | 28 | −12.18 | −34.30, 9.94 | 0.2686 |
| 4 weeks—baseline | 37 | −16.26a | −27.40, −5.13 | 0.0054 |
| Hamilton anxiety rating—somatic subscale | ||||
| 12 weeks—baseline | 28 | −67.53a | −91.08, −43.99 | <0.0001 |
| 12–4 weeks | 25 | −50.00a | −82.23, −17.77 | 0.0437 |
| 12–8 weeks | 20b | −19.48 | −45.21, 6.25 | 0.1296 |
| 8–4 weeks | 26 | −7.60 | −37.62, 22.42 | 0.6067 |
| 4 weeks—baseline | 37 | −24.85a | −41.72, −7.98 | 0.0050 |
Table 3
| Unexpected events | Related to supplement intake | Number of cases ( | ||
|---|---|---|---|---|
| 4 weeks | 8 weeks | 12 weeks | ||
| Diuresis increase (related to higher water intake) | Yes | 2 | — | — |
| Unpleasant herbal aftertaste | Yes | 5 | 1 | 1 |
| Slight feeling of nausea | Yes | 2 | — | — |
| Insomnia | Possibly | 1 | 1 | — |
| Constipation | Possibly | — | — | 1 |
| Fluid retention | Probably | — | — | 1 |
| Total | — | 8 | 2 | 3 |
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