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Comparative Efficacy and Acute Tolerability of a Standardized Withania somnifera Root Extract Versus Sertraline in Generalized Anxiety Disorder: A Randomized, Double-Blind, Placebo-Controlled Non-Inferiority Trial Ni Made Nova Indriani; Suyong Zhou; Riri Arisanty Syafril Lubis; Jason Willmare
Eureka Herba Indonesia Vol. 6 No. 1 (2025): Eureka Herba Indonesia
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/ehi.v6i1.132

Abstract

Generalized anxiety disorder (GAD) represents a significant psychiatric burden, characterized by chronic hyperarousal and dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis. While selective serotonin reuptake inhibitors (SSRIs) like Sertraline are the standard of care, their utility is often compromised by delayed onset and adverse effects, specifically sexual dysfunction. Withania somnifera (Ashwagandha) acts as a GABA-mimetic and adaptogen, yet rigorous head-to-head comparisons against pharmaceutical controls are rare. We conducted an 8-week, randomized, double-blind, placebo-controlled trial involving 150 adults with DSM-5 diagnosed GAD. Participants were randomized (1:1:1) to receive High-Concentration Ashwagandha Root Extract (600 mg/day, standardized to >5% withanolides), Sertraline (50 mg/day), or Placebo. Blinding was maintained using mint-scented desiccants to mask the herb's odor. Efficacy was analyzed using Mixed Models for Repeated Measures (MMRM). Of 150 participants, 138 completed the study. Both Ashwagandha (Mean HAM-A reduction -14.2) and Sertraline (-15.1) demonstrated statistical superiority over Placebo (-5.4; p < 0.001). The difference between active arms was not statistically significant, supporting comparable efficacy. Ashwagandha significantly reduced serum cortisol (-24.3%) and improved GAD-7 scores. Crucially, while Sertraline induced significant sexual dysfunction (worsened ASEX scores, p < 0.001) and nausea (28%), Ashwagandha showed a safety profile indistinguishable from placebo. In conclusion, standardized Withania somnifera extract (600 mg/day) offers anxiolytic efficacy comparable to Sertraline (50 mg/day) with a superior safety profile, specifically devoid of sexual and gastrointestinal adverse effects.
Sociocultural Determinants of Clinical Autopsy Refusal and Their Medicolegal Impact on Diagnostic Accuracy in Indonesian Tertiary Hospitals Yuniarti Maretha Pasaribu; Riri Arisanty Syafril Lubis; Franklin Shane; Lisye Tiur Simanjuntak
Sriwijaya Journal of Forensic and Medicolegal Vol. 3 No. 2 (2025): Sriwijaya Journal of Forensic and Medicolegal
Publisher : Phlox Institute: Indonesian Medical Research Organization

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.59345/sjfm.v3i2.252

Abstract

Introduction: Clinical autopsy refusal remains a critical barrier to diagnostic quality assurance and medicolegal accountability in Indonesian hospital medicine. This retrospective cohort study enrolled 324 consecutive inpatient deaths across three tertiary referral hospitals in Palembang, South Sumatra (January 2019 – December 2023), to characterize sociocultural determinants of autopsy refusal and their impact on diagnostic accuracy and time-to-correct-diagnosis. Methods: The primary outcome was next-of-kin refusal of clinical autopsy consent; secondary outcomes included diagnostic discrepancy classified by the Goldman system, and time-to-correct-diagnosis analyzed by Kaplan-Meier survival analysis with log-rank testing. Multivariate logistic regression with bootstrap-derived confidence intervals identified independent predictors of refusal. Results: The overall autopsy refusal rate was 84.0% (272/324). Independent predictors were Javanese ethnicity (OR 3.64, 95% CI 1.77–7.48; p<0.001), Islamic religious affiliation (OR 2.49, 95% CI 1.42–4.37; p=0.001), primary or no formal education (OR 2.36, 95% CI 1.19–4.68; p=0.014), age per 10-year increment (OR 1.18, 95% CI 1.05–1.33; p=0.006), and low household income below 2 million IDR (OR 1.76, 95% CI 1.00–3.10; p=0.049). The model demonstrated good discrimination (C-statistic 0.81) and calibration (Hosmer-Lemeshow p=0.43). Major diagnostic discrepancy (Goldman Class I–II) occurred in 26.1% of the refused cohort versus 13.5% in the consented cohort (p=0.047). Median time-to-correct-diagnosis was 19 days (95% CI 15–24) in the refused group versus 5 days (95% CI 3–8) in the consented group (log-rank p<0.001). Conclusion: These findings provide robust evidence for the medicolegal urgency of addressing sociocultural barriers to autopsy consent through culturally sensitive policy reform in Indonesia.