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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 citas

Etiquetas de revisión

Financiación no declarada

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Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento

Quién lo pagó

Financiación
Financiación no declarada

Publicación

Publicado
2018-07-09 · J Clin Psychiatry · vol. 79 · número 5
Editorial
Physicians Postgraduate Press, Inc.
Citado
73 citas · más que el 98% de estudios similares · 9.6× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
0 trabajos
Acceso
De pago
Áreas de investigación
Phytochemicals and Medicinal Plants · Tryptophan and brain disorders · Schizophrenia research and treatment
Palabras clave
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 autores

  • K. N. Roy Chengappa🇺🇸 · autor de correspondenciaUniversity of Pittsburgh; University of Pittsburgh Medical Center
  • Jaspreet Singh Brar🇺🇸University of Pittsburgh Medical Center
  • Jessica M. Gannon🇺🇸University of Pittsburgh; University of Pittsburgh Medical Center
  • Patricia J. Schlicht🇺🇸University of Pittsburgh Medical Center

Resumen

El texto original del estudio, en el idioma en que se publicó.

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.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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