Adjunctive Use of a Standardized Extract of Withania somnifera (Ashwagandha) to Treat Symptom Exacerbation in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Study
Chengappa KNR, Brar JS, Gannon JM, Schlicht PJ
The Journal of clinical psychiatry · 52 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
- 2018-07-09 · J Clin Psychiatry · vol. 79 · issue 5
- Publisher
- Physicians Postgraduate Press, Inc.
- Cited
- 73 citations · more than 98% of similar papers · 9.6× the field average
- Impact
- Top 10% most cited in its field
- References
- 0 works
- Access
- Paywalled
- Research areas
- Phytochemicals and Medicinal Plants · Tryptophan and brain disorders · Schizophrenia research and treatment
- Keywords
- Withania somnifera, Schizophrenia (object-oriented programming), Exacerbation, Adjunctive treatment, Medicine, Psychiatry, Traditional medicine, Internal medicine, Alternative medicine
- MeSH
- humans, c-reactive protein, antipsychotic agents, plant extracts, treatment outcome, phytotherapy, drug therapy, combination, double-blind method, psychotic disorders, schizophrenia, adolescent, adult, aged, middle aged, female, male, young adult, s100 calcium binding protein beta subunit
4 authors
From US
- K. N. Roy Chengappa · correspondingUniversity of Pittsburgh; University of Pittsburgh Medical Center
- Jaspreet Singh BrarUniversity of Pittsburgh Medical Center
- Jessica M. GannonUniversity of Pittsburgh; University of Pittsburgh Medical Center
- Patricia J. SchlichtUniversity of Pittsburgh Medical Center
Abstract
Objective
To determine if adjunctive treatment with a standardized extract of Withania somnifera (WSE), with known anti-inflammatory and immunomodulating properties, improves psychopathology and stress in patients with schizophrenia or schizoaffective disorder (DSM-IV-TR).
Methods
Patients experiencing an exacerbation of symptoms were assigned to WSE (1,000 mg/d) or placebo for 12 weeks, added to their antipsychotic medication, in a random-assignment, double-blind, placebo-controlled study conducted from April 2013 to July 2016. Primary outcomes were change from baseline to end of treatment on the Positive and Negative Syndrome Scale (PANSS total, positive, negative, and general symptoms) between treatment groups. Secondary outcomes evaluated stress and inflammatory indices using the Perceived Stress Scale (PSS), S100 calcium-binding protein B (S100B), and C-reactive protein (CRP).
Results
Sixty-six randomized patients (n = 33 per group) provided efficacy data. Beginning at 4 weeks and continuing to the end of treatment, WSE produced significantly greater reductions in PANSS negative, general, and total symptoms (Cohen d: 0.83, 0.76, 0.83), but not positive symptoms, when compared to placebo. PSS scores improved significantly with WSE treatment compared to placebo (Cohen d: 0.58). CRP and S100B declined more in the WSE group but were not significantly different from placebo. Adverse events were mild to moderate and transient; somnolence, epigastric discomfort, and loose stools were more common with WSE. No significant between-treatment differences were noted in body weight, vital signs, or laboratory measures, which remained stable.
Conclusions
This early study suggests that adjunctive treatment with a standardized extract of Withania somnifera provides significant benefits, with minimal side effects, for negative, general, and total symptoms and stress in patients with recent exacerbation of schizophrenia.
Trial registration
ClinicalTrials.gov identifier: NCT01793935.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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