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 trích dẫn
PubMed
DOI
CC-BY
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Study Design
- Loại nghiên cứu
- open-label prospective trial
- Can thiệp
- 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)
- Đối chứng
- Placebo
- Xu hướng hiệu quả
- Positive
- Nguy cơ sai lệch
- 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 |
References
- Mental Disorders Collaborators. Global Prevalence and Burden of Depressive and Anxiety Disorders in 204 Countries and Territories in 2020 due to the COVID-19 Pandemic Lancet, 2021
- Disease and Injuries Collaborators. Global Burden of 369 Diseases and Injuries in 204 Countries and Territories, 1990–2019: A Systematic Analysis for the Global Burden of Disease Study 2019 Lancet, 2019
- COVID-19 Pandemic and Mental Health Consequences: Systematic Review of the Current Evidence Brain, Behavior, and Immunity, 2020
- The Impacto f COVID-10 on Mental Health Cannot Be Made Light of
- The Impact of COVID-19 Traumatic Stressors on Mental Health: Is COVID-19 a New Trauma Type International Journal of Mental Health and Addiction, 2023
- Psychological Factors Explaining the COVID-19 Pandemic Impact on Mental Health: The Role of Meaning, Beliefs, and Perceptions of Vulnerability and Mortality Behavioral Sciences, 2023
- The Psychological and Mental Impact of Coronavirus Disease 2019 (COVID-19) on Medical Staff and General Public— A Systematic Review and Meta-Analysis Psychiatry Research, 2020
- Impacts of Working From Home During COVID-19 Pandemic on Physical and Mental Well-Being of Office Workstation Users Journal of Occupational & Environmental Medicine, 2021
- Occupational Profile, Psychosocial Aspects, and Work Ability of Brazilian Workers During COVID-19 Pandemic: IMPPAC Cohort Safety and Health at Work, 2022
- Uncertainty and Psychological Distress During COVID-19: What About Protective Factors? Current Psychology, 2022
- National Institute on Drug Abuse Website
- Consensus Guide for the Proper use of Benzodiazepines Risk and Benefit Management Socidrogalcohol, 2019
- Medicinal Plants Used for Anxiety, Depression, or Stress Treatment: An Update Molecules, 2022
- A Comprehensive Review of the Pharmacological Potential of Crocus sativus and Its Bioactive Apocarotenoids Biomedicine & Pharmacotherapy, 2018
- Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Insomnia and Anxiety: A Double-Blind, Randomized, Placebo-Controlled Study Cureus, 2019
- Does Ashwagandha Supplementation Have a Beneficial Effect on the Management of Anxiety and Stress? A Systematic Review and Meta-Analysis of Randomized Controlled Trials Phytotherapy Research, 2022
- L-Tryptophan: Basic Metabolic Functions, Behavioral Research and Therapeutic Indications International Journal of Tryptophan Research, 2009
- Tryptophan Catabolism and Vitamin B-6 Status Are Affected by Gender and Lifestyle Factors in Healthy Young Adults The Journal of Nutrition, 2015
- Vitamin B6: A New Approach to Lowering Anxiety, and Depression? Annals of Medicine and Surgery, 2022
- Efficacy of Crocus sativus (Saffron) in Treatment of Major Depressive Disorder Associated With Post-Menopausal Hot Flashes: A Double-Blind, Randomized, Placebo-Controlled Trial Archives of Gynecology and Obstetrics, 2018
- Saffron and Crocin Improved Appetite, Dietary Intakes and Body Composition in Patients With Coronary Artery Disease Journal of Cardiovascular and Thoracic Research, 2017
- A Double-Blind, Randomized, Placebo-Controlled Trial of Saffron Stigma (Crocus sativus L.) in Mothers Suffering From Mild-to-Moderate Postpartum Depression Phytomedicine, 2017
- Comparison of Saffron Versus Fluoxetine in Treatment of Mild to Moderate Postpartum Depression: A Double-Blind, Randomized Clinical Trial Pharmacopsychiatry, 2017
- Crocus sativus L. versus Citalopram in the Treatment of Major Depressive Disorder With Anxious Distress: A Double-Blind, Controlled Clinical Trial Pharmacopsychiatry, 2017
- A Double-Blind, Randomized and Placebo-Controlled Trial of Saffron (Crocus sativus L.) in the Treatment of Anxiety and Depression Journal of Complementary and Integrative Medicine, 2016
- A Randomized, Double-Blind, Clinical Trial Comparing the Efficacy and Safety of Crocus sativus L. With Fluoxetine for Improving Mild to Moderate Depression in Post Percutaneous Coronary Intervention Patients Journal of Affective Disorders, 2014
- Comparison of Petal of Crocus sativus L. and Fluoxetine in the Treatment of Depressed Outpatients: A Pilot Double-Blind Randomized Trial Progress in Neuro-Psychopharmacology and Biological Psychiatry, 2007
- Crocus sativus L. (petal) in the Treatment of Mild-to-Moderate Depression: A Double-Blind, Randomized and Placebo-Controlled Trial Phytomedicine, 2006
- Hydro-Alcoholic Extract of Crocus sativus L. versus Fluoxetine in the Treatment of Mild to Moderate Depression: A Double-Blind, Randomized Pilot Trial Journal of Ethnopharmacology, 2005
- Crocus sativus L. in the Treatment of Mild to Moderate Depression: A Double-Blind, Randomized and Placebo-Controlled Trial Phytotherapy Research, 2005
- The effects of saffron (Crocus sativus L.) on mental health parameters and C-reactive protein: A meta-analysis of randomized clinical trials Complementary Therapies in Medicine, 2020
- Diagnosis and Rating of Anxiety British Journal of Psychiatry, 1969
- Validation of the Spanish Versions of the Montgomery–Asberg Depression and Hamilton Anxiety Rating Scales) Medical & Clinical Research, 2002
- Review of the Test Used for Measuring Therapeutic Compliance in Clinical Practice Atencion Primaria, 2008
- Evaluation in the Clinic of Health-Related Quality of Life: The COOP/WONCA Cartoons Atencion Primaria, 2002
- Functional Status in Primary Care: COOP/WONCA Charts Disability and Rehabilitation, 2009
- Emotional Distress and Health-Related Quality of Life in Patients on Hemodialysis: The Clinical Value of COOP-WONCA Charts Journal of Nephrology, 2007
- Mass Quarantine and Mental Health During COVID-19: A Meta-Analysis Journal of Affective Disorders, 2021
- Nutrients and Herbal Supplements for Mental Health Australian Prescriber, 2014
- Saffron: A Potential Drug-Supplement for Severe Acute Respiratory Syndrome Coronavirus (COVID) Management Heliyon, 2021
- The Effects of Saffron (Crocus sativus L.) on Mental Health Parameters and C-Reactive Protein: A Meta-Analysis of Randomized Clinical Trials Complementary Therapies in Medicine, 2020
- Effect of Saffron Supplementation on Symptoms of Depression and Anxiety: A Systematic Review and Meta-Analysis Nutrition Reviews, 2019
- Saffron in the Treatment of Depression, Anxiety and Other Mental Disorders: Current Evidence and Potential Mechanisms of Action Journal of Affective Disorders, 2018
- Differential Association of Somatic and Cognitive Symptoms of Depression and Anxiety With Inflammation: Findings From the Netherlands Study of Depression and Anxiety (NESDA) Psychoneuroendocrinology, 2013
- Ghayour-Mobarhan M. Depression and Anxiety Symptoms Are Associated With White Blood Cell Count and Red Cell Distribution Width: A Sex-Stratified Analysis in a Population-Based Study Psychoneuroendocrinology, 2017
- Anti-Inflammatory Activity of Crocus sativus Extract in Experimental Arthritis International Journal of Pharmaceutical Sciences and Research, 2015
- Anti-Asthma Potential of Crocin and Its Effect on MAPK Signaling Pathway in a Murine Model of Allergic Airway Disease Immunopharmacology and Immunotoxicology, 2015
- Dietary Crocin Inhibits Colitis and Colitis-Associated Colorectal Carcinogenesis in Male ICR Mice Evidence-Based Complementary and Alternative Medicine, 2012
- Major Depressive Disorder Is Accompanied With Oxidative Stress: Short-Term Antidepressant Treatment Does Not Alter Oxidative-Antioxidative Systems Human Psychopharmacology: Clinical and Experimental, 2007
- Depression and Oxidative Stress: Results From a Meta-Analysis of Observational Studies Psychosomatic Medicine, 2014
- Is Depression Associated With Increased Oxidative Stress? A Systematic Review and Meta-Analysis Psychoneuroendocrinology, 2015
- Potential of Crocus sativus (saffron) and Its Constituent, Crocin, as Hypolipidemic and Antioxidant in Rats Applied Biochemistry and Biotechnology, 2010
- Alterations of Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Depressed Patients With or Without Antidepressants Biological Psychiatry, 2003
- Antidepressant Effects of Crocin and Its Effects on Transcript and Protein Levels of CREB, BDNF, and VGF in Rat Hippocampus DARU Journal of Pharmaceutical Sciences, 2014
- Antidepressant Effect of Crocus sativus Aqueous Extract and Its Effect on CREB, BDNF, and VGF Transcript and Protein Levels in Rat Hippocampus Drug Research, 2015
- The HPA Axis in Major Depression: Classical Theories and New Developments Trends in Neurosciences, 2008
- Antidepressants and Hypothalamic-Pituitary-Adrenocortical Regulation Endocrine Reviews, 1996
- Reduction of Metabolic and Behavioral Signs of Acute Stress in Male Wistar Rats by Saffron Water Extract and Its Constituent Safranal Pharmaceutical Biology, 2011
- Saffron (Crocus sativus) Aqueous Extract and Its Constituent Crocin Reduces Stress-Induced Anorexia in Mice Phytotherapy Research, 2011
- Protective Effects of Saffron Extract and Its Active Constituent Crocin Against Oxidative Stress and Spatial Learning and Memory Deficits Induced by Chronic Stress in Rats European Journal of Pharmacology, 2011
- Psychological and Neuroendocrinological Effects of Odor of Saffron (Crocus sativus) Phytomedicine, 2011
- Direct Evidence for GABAergic Activity of Withania somnifera on Mammalian Ionotropic GABAA and GABAρ Receptors Journal of Ethnopharmacology, 2015
- Adaptogenic Activity of Withania somnifera: An Experimental Study Using a Rat Model of Chronic Stress Pharmacology Biochemistry and Behavior, 2003
- GABA-Mimetic Actions of Withania somnifera on Substantia Gelatinosa Neurons of the Trigeminal Subnucleus Caudalis in Mice The American Journal of Chinese Medicine, 2013
- The GABAergic Deficit Hypothesis of Major Depressive Disorder Molecular Psychiatry, 2011
- A Standardized Withania somnifera Extract Significantly Reduces Stress-Related Parameters in Chronically Stressed Humans: A Double-Blind, Randomized, Placebo-Controlled Study Journal of the American Nutrition Association, 2008
- Gender and the Relationship Between Marital Status and First Onset of Mood, Anxiety and Substance Use Disorders Psychological Medicine, 2010
- Women During the Covid-19 Lockdown: More Anxiety Symptoms in Women With Children Than Without Children and Role of the Resilience Mediterranean Journal of Clinical Psychology, 2020
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