ABSTRACT
BACKGROUND: Stress is a known causative factor in modulating cognitive health, which overall well-being and quality of life are dependent on. Long-term stress has been shown to disrupt the balance of the hypothalamic-pituitary-adrenal (HPA) axis. Adaptogens, such as Withania somnifera (ashwagandha), are commonly used in Ayurvedic medicine for stress relief and ameliorating HPA-axis dysfunction. The aim of this study was to support the role of a root and leaf water-extracted ashwagandha extract (WS) in stress reduction by confirming the lowest clinically validated dose for stress management (125 mg/day) in a dose-dependent clinical study in adults with self-reported high stress. METHODS: An 8-week, randomized, double-blinded, placebo-controlled study to compare the effects of three different WS extract doses (125, 250 and 500 mg) was performed. A total of 131 adults were enrolled, and 98 were included in the final analysis. Attenuation of chronic stress was measured using the 14-item Perceived Stress Scale (PSS) and biochemical-related stress parameters. RESULTS: We have shown that aqueous WS extract (roots and leaves) safely reduces mild to moderate chronic stress at doses of 125 mg, 250 mg, and 500 mg/day for 8 weeks. CONCLUSIONS: Our findings demonstrate the stress-reduction capabilities of this well-characterized aqueous extract of WS (root and leaf) at the low dose of 125 mg/day, in a dose-dependent manner, via the modulation of the HPA axis. TRIAL REGISTRATION: This study was registered with the Clinical Trials Registry-India (CTRI) with the registration number: CTRI/2019/11/022100.
Subject(s)
Plant Extracts , Plant Leaves , Plant Roots , Stress, Psychological , Withania , Humans , Withania/chemistry , Plant Extracts/pharmacology , Male , Female , Adult , Double-Blind Method , Stress, Psychological/drug therapy , Plant Leaves/chemistry , Middle Aged , Plant Roots/chemistry , Hypothalamo-Hypophyseal System/drug effects , Chronic Disease , Medicine, Ayurvedic , Pituitary-Adrenal System/drug effects , Young Adult , PhytotherapyABSTRACT
BACKGROUND: The routine use of antibiotic-loaded bone cement (ABLC) during primary or uninfected revision arthroplasty remains controversial. Many studies quote the total joint arthroplasty (TJA) infection rate to be less than 1%. Total knee arthroplasty (TKA) has a higher infection rate than total hip arthroplasty (THA). Based on both animal and human studies in the past, ABLC has been found effective in reducing the risk of infection in primary TJA. We are presenting retrospective analysis of results in terms of infection rate in 659 TKA performed by a single surgeon under similar conditions during 2004-2007 using CMW1 (Depuy, Leeds, UK) with premixed 1 g of gentamicin. PATIENTS AND METHODS: We did primary TKA in 659 knees of 379 patients during 2004-2007 using CMW1 (Depuy, Leeds, UK) cement containing 1 g of gentamicin in 40 g of cement in a premixed form. Standard OT conditions were maintained using laminar air flow, isolation suits for the operating team, pulse lavage and disposable drapes in each patients. Midvastus approach was used in all the patients to expose the knee joint. A systemic antibiotic (third-generation cephalosporin and aminoglycoside) was used preoperatively and 48 h postoperatively. We observed the patients in terms of infection in the high-risk and low-risk group till the recent follow-up with a mean of 20.6 months (9-38 months). RESULTS: We had deep infection in six knees in six patients and all of them required two-stage revision surgery later in the high-risk group. Infection occurred at a mean of 20.5 months after surgery earliest at 9 months and latest at 36 months after surgery. The infection rate in our study was 0.91% which is comparatively less than the reported incidence of 1-2% in reported studies. CONCLUSION: We conclude that the use of antibiotic loaded bone cement is one of the effective means in preventing infection in primary TJA.
