אשווגנדה היא עשב שניתן לקנות ללא מרשם רופא.

Ashwagandha is a herb that can be bought without a prescription.

Ashwagandha (Withania somnifera, Solanaceae)SchizophreniaAdjunct TherapyDate: 02-28-2020HC# 071955-635

Re: Adjunct Ashwagandha Reduces Symptom Severity in Patients with SchizophreniaChengappa KNR, Brar JS, Gannon JM, Schlicht PJ. Adjunctive use of a standardized extract of Withania somnifera (ashwagandha) to treat symptom exacerbation in schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. July 10, 2018;79(5):pii: 17m11826. doi: 10.4088/JCP.17m11826.Alterations in immune-inflammatory cytokines and proteins may contribute to the symptoms of schizophrenia. Antipsychotic medications do not mitigate immune-inflammatory disturbances. Anti-inflammatory drugs may be used as an adjunct therapy; however, they are associated with unwanted side effects. Ashwagandha (Withania somnifera, Solanaceae) root extract has demonstrated immunomodulatory and anti-inflammatory properties but lacks the typical anti-inflammatory side effects. The purpose of this randomized, double-blind, placebo-controlled study was to evaluate the efficacy and safety of ashwagandha as an adjunct therapy in adults with exacerbated schizophrenia symptoms.Male and female outpatients (n = 68, aged 18 to 75 years) with schizophrenia or schizoaffective disorder, according to Statistical Manual of Mental Disorders, fourth edition (DSM-IV-TR) participated in this study from April 2013 to July 2016 at the ambulatory clinics associated with Comprehensive Recovery Services of Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center; Pittsburgh, Pennsylvania. Included patients had the diagnosis confirmed by the Mini-International Neuropsychiatric Interview; had a Positive and Negative Syndrome Scale (PANSS) total score ≥ 60, with a score ≥ 5 on any one item or a score ≥ 4 on any two items of the positive symptom cluster or unusual thought content; symptom exacerbation occurred for ≥ two weeks but ≤ one year; and patients had to be receiving antipsychotic agents for ≥ four weeks. Symptom exacerbation was defined using a combination of patient self-reporting and clinician or referring psychiatrist confirmation. Exclusion criteria were as follows: positive pregnancy test or breastfeeding; positive test for illicit drugs (marijuana [Cannabis sativa, Cannabaceae] bud/leaf and alcohol use were allowed on a case by case basis); unstable medical disorders; known allergy to ashwagandha; required psychiatric hospitalization; or receiving antibiotic, antiviral, antiparasitic, immunosuppressive, or daily non-steroidal anti-inflammatory drugs.Referring psychiatrists were permitted to increase the dosage of an antipsychotic drug, add a second antipsychotic drug, change the dose of mood stabilizers and antidepressants, and add sedative-hypnotic agents. However, patients were excluded if they were switched to another antipsychotic drug.The ashwagandha group received 500 mg/d ashwagandha (Sensoril; Natreon, Inc.; New Brunswick, New Jersey) for the first week, then 1,000 mg/d for 11 weeks. According to the manufacturer’s web site, Sensoril is a patented, standardized aqueous extract of ashwagandha root and leaf containing ≥10% withanolide glycosides. The placebo group received capsules containing the excipients of the ashwagandha product, which had been stored in pouches containing ashwagandha so that the placebo smelled like ashwagandha. The primary outcome measure was PANSS change scores (total, positive, negative, and general symptoms). Secondary outcome measures included the Perceived Stress Scale (PSS), Clinical Global Impressions (CGI), and serum levels of the cytokines interleukin (IL)-2, IL-4, IL-6, and interferon (IFN)-γ, and the inflammatory markers high sensitivity C-reactive protein (hsCRP) and S100B.Baseline characteristics were similar between groups. The intent to treat population was composed of 66 patients as one patient in each group did not take the allocated treatment. Five patients in the ashwagandha group and two in the placebo group were discontinued from the study; two patients in the ashwagandha group discontinued due to adverse effects (AEs). There were 59 patients who completed the study per protocol, 28 in the ashwagandha group and 31 in the placebo group. Compliance was 82-100%.The ashwagandha group had significant improvement compared with placebo on the mean PANSS negative (P = 0.001), general (P = 0.003), and total (P = 0.001) symptom scores; the Cohen’s d effect sizes for the total and negative change scores were large (d = 0.83 for both) and medium for general symptom change score (d = 0.76). Mean PANSS positive symptom change score for the ashwagandha group approached but did not reach statistical significance (P = 0.055). Post-hoc subgroup analyses based on baseline PANSS scores showed that the effect size for the nine patients with moderate severity PANSS negative symptom scores (d = 1.61) was nearly double that of the entire cohort (d = 0.83). The ashwagandha group had significant reductions in mean PSS score compared to placebo starting at four weeks and persisting through to the end of the study (P = 0.012). Compared to placebo, the ashwagandha group was significantly more likely to achieve ≥ 20% improvement in PANSS negative (P = 0.002), general (P = 0.013), and total symptom scores (P = 0.013), and PSS score (P = 0.012). CGI score, cytokine levels, and inflammatory marker concentrations did not significantly differ between the groups. The incidence of AEs did not significantly differ between groups and all reported AEs were classified as mild-to-moderate and transient.The authors conclude that adjunct therapy with ashwagandha “provides significant benefits, with minimal side effects, for negative, general, and total symptoms and stress in patients with recent exacerbation of schizophrenia.” While this dose of ashwagandha was well-tolerated, the authors point out that the optimum dosage has not been determined. Acknowledged limitations of this study include the small sample size, relatively short duration, lack of post-treatment follow-up, and other inflammatory indices and cognitive benefits were not evaluated. Natreon, Inc. provided the ashwagandha and placebo treatments but had no role in the conduct of the study, data analysis, or reporting.—Heather S. Oliff, PhD

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