Assessment of the Efficacy of <i>Withania somnifera</i> Root Extract in Patients with Generalized Anxiety Disorder: A Randomized Double-blind Placebo- Controlled Trial
Fuladi S, Emami SA, Mohammadpour AH, Karimani A, Manteghi AA, Sahebkar A
Current reviews in clinical and experimental pharmacology · 20 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2020-04-13 · Curr Rev Clin Exp Pharmacol · vol. 16 · issue 2 · pp. 191–196
- Publisher
- Bentham Science Publishers
- Cited
- 33 citations · more than 94% of similar papers · 4.5× the field average
- Impact
- Top 10% most cited in its field
- References
- 0 works
- Access
- Paywalled
- Research areas
- Phytochemicals and Medicinal Plants · Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes · Medicinal Plant Extracts Effects
- Keywords
- Generalized anxiety disorder, Withania somnifera, Discontinuation, Placebo, Randomized controlled trial, Medicine, Hamilton Anxiety Rating Scale, Anxiety, Anxiolytic, Population, Psychiatry, Internal medicine, Pathology, Alternative medicine
- MeSH
- humans, withania, anti-anxiety agents, plant extracts, anxiety disorders, iran
6 authors
From IR
- Sara FuladiMashhad University of Medical Sciences
- Seyed Ahmad EmamiMashhad University of Medical Sciences
- Amir Hooshang MohammadpourMashhad University of Medical Sciences
- Asieh KarimaniMashhad University of Medical Sciences
- Ali Akhondpour Manteghi · correspondingMashhad University of Medical Sciences
- Amirhossein SahebkarMashhad University of Medical Sciences; Biotechnology Research Center
Abstract
Background
Anxiety disorders are the most universal psychiatric problems in the general population. Due to their chronic nature, these diseases are managed with a multi-drug regimen lasting for a long period of time. Medication discontinuation leads to 25% and 80% recurrence in the first month and the first year, respectively. Despite several treatment approaches, there is no specific and optimal method for patient management. Therefore, it is necessary to find some new therapeutic approaches with fewer side effects. Withania somnifera is a plant with GABAergic property responsible for its anxiolytic effect. The aim of this study was to investigate the effect of W. somnifera root extract as an alternative therapy to reduce standard Generalized Anxiety Disorder (GAD) symptoms.
Methods
Forty patients who met the inclusion criteria (with a confirmed diagnosis of GAD as stated in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) took part in this randomized double-blind placebo-controlled trial and were randomly selected for participation in the treatment group (W. somnifera extract, 1g/day; n = 22) or the placebo group (n = 18). All patients were under treatment with Selective Serotonin Reuptake Inhibitors (SSRIs) and were prescribed one capsule of the extract or placebo per day for six weeks. The Hamilton anxiety rating scale (HAM-A) was used to assess the severity of GAD symptoms at baseline as well as the second and sixth weeks of the trial.
Results
Comparison of the HAM-A scores during the course of the trial revealed a significant amelioration ofHAM-A score in the treatment group versus placebo (14 and 8 units reduction, respectively (P < 0.05)). Moreover, there was a significant difference in the reduction of GAD score between the second (P =0.04) and sixth week (P =0.02) in the treatment group. The extract was safe and no adverse effect was observed during the trial.
Conclusion
W. somnifera extract offers some potential advantages as a safe and effective adjunctive therapy to SSRIs in GAD. The clinical trial protocol has been registered under the Iranian Registry of Clinical Trials (IRCT20180615040105N1).
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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