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Fuladi S, Emami SA, Mohammadpour AH, Karimani A, Manteghi AA, Sahebkar A. Evaluation of the effectiveness of Withania somnifera root extract in patients with generalized anxiety disorder: a randomized, double-blind, placebo-controlled trial.Curr Clin Pharmacol. Published online on April 13, 2020. doi: 10.2174/1574884715666200413120413.
Study objective
To assess the effect of an extractWithania somniferafor symptoms of generalized anxiety
Draft
Randomized, double-blind, placebo-controlled trial
Participant
This study involved 40 patients undergoing treatment with selective serotonin reuptake inhibitors (SSRIs). They met the criteria for a diagnosis of generalized anxiety disorder (GAD) as described in theDiagnostic and Statistical Manual of Mental Disorders,Fourth edition, text revision(DSM-IV-TR). They were randomly selected for the treatment group (W Somniferaroot extract, 1 g/day; n=22) or the placebo group (n=18). Patients received either the extract or placebo daily for 6 weeks.
Study parameters assessed
To assess the severity of GAD symptoms at baseline and at Week 2 and Week 6 of the study, researchers used the Hamilton Anxiety Rating Scale (HAM-A). The HAM-A scale contains 14 questions that rate the severity of common GAD symptoms from 0 to 4.
Primary outcome measures
HAM-A scores over the course of the study showed significant improvement in GAD symptoms in the treatment group versus placebo (P<0.05). There was also a significant difference in GAD score reduction between the 2nd(P=0.04) and 6th week (P=0.02) in the treatment group. The extract was safe and researchers observed no adverse effects during the study.
Key insights
Withania somnifera(Ashwagandha) root extract is statistically effective at 1 gram per day after 2 weeks and even more so after 6 weeks of treatment. It has also been found to be safe to use while taking SSRIs.
Practice implications
In alternative medical care, many patients seek treatment for anxiety and related conditions such as insomnia, chronic stress and muscle tension. Many of the medications available have side effects. For example, the commonly prescribed benzodiazepine lorazepam can cause dizziness, weakness, lightheadedness, and fatigue. It can also take some getting used to.1Studies show thisWithania somniferareduces stress, lowers serum cortisol levels and enhances GABA signaling in the central nervous system.2-5
Withania somniferahas a long history of use in Ayurveda. A randomized, double-blind, placebo-controlled trial conducted in India with a total of 60 patients over 10 weeks used a high potency, full-spectrum root extract of 300 mg twice daily.2The study monitored sleep onset latency, sleep efficiency, sleep quality, total sleep time and anxiety levels. There was a significant improvement in all parameters. Sleep effectiveness was observed to continue to increase from baseline after 10 weeks, suggesting that long-term treatment is best. Larger studies are needed to confirm these results. Another similarly structured study in 2019 found a significant improvement in sleep, a reduction in perceived stress (P<0.05 andP<0.001), decreased cortisol levels (P<0.05 andP<0.0001) with 125 mg or 300 mgWithania somniferatwice a day.3
Withania somniferahas been used safely in combination with SSRIs, a class of medications that often precludes the use of many other natural agents.
Another study with 64 participants evaluated the safety and effectiveness of highly concentrated full-spectrum extractWithania somniferaas an adaptogen. The randomized, double-blind, placebo-controlled study focused on people affected by chronic stress and included serum cortisol as a marker. After 60 days, serum cortisol levels were significantly reduced (P=0.0006) in theWithania somniferagroup relative to the placebo group. No adverse events were reported. That's what the authors concludedWithania somniferais safe and effective in improving stress resistance and can therefore improve quality of life.4
Gamma-aminobutyric acid (GABA) signaling disorder is associated with generalized anxiety disorder, insomnia, muscle spasms, and seizures.6-9One study used microtransplanted eggs to examine GABA receptors and their sensitivity toWithania somnifera.5The study showed for the first time that an aqueous extract ofWithania somniferais a potent agonist of GABAp1 receptors, and this activation was not significantly different from that produced by exogenous GABA.
In line with the traditional Ayurvedic use ofWithania somnifera, clinical studies have shown that it may be useful for patients with GAD, sleep onset and sleep quality problems, elevated cortisol levels, and other stress-related conditions such as muscle tension. A key takeaway from the current study is thisWithania somniferahas been used safely in combination with SSRIs, a class of medications that often precludes the use of many other natural agents.