Background:Ashwagandha (Withania somnifera (L.) Dunal) is a herb traditionally used to reduce stress and enhance wellbeing. The aim of this study was to investigate its anxiolytic effects on adults with self-reported high stress and to examine potential mechanisms associated with its therapeutic effects.Methods:In this 60-day, randomized, double-blind, placebo-controlled study the stress-relieving and pharmacological activity of an ashwagandha extract was investigated in stressed, healthy adults. Sixty adults were randomly allocated to take either a placebo or 240 mg of a standardized ashwagandha extract (Shoden) once daily. Outcomes were measured using the Hamilton Anxiety Rating Scale (HAM-A), Depression, Anxiety, and Stress Scale -21 (DASS-21), and hormonal changes in cortisol, dehydroepiandrosterone-sulphate (DHEA-S), and testosterone.Results:All participants completed the trial with no adverse events reported. In comparison with the placebo, ashwagandha supplementation was associated with a statistically significant reduction in the HAM-A (P = .040) and a near-significant reduction in the DASS-21 (P = .096). Ashwagandha intake was also associated with greater reductions in morning cortisol (P < .001), and DHEA-S (P = .004) compared with the placebo. Testosterone levels increased in males (P = .038) but not females (P = .989) over time, although this change was not statistically significant compared with the placebo (P = .158).Conclusions:These findings suggest that ashwagandha's stress-relieving effects may occur via its moderating effect on the hypothalamus-pituitary-adrenal axis. However, further investigation utilizing larger sample sizes, diverse clinical and cultural populations, and varying treatment dosages are needed to substantiate these findings.Trial registration:Clinical Trials Registry—India (CTRI registration number: CTRI/2017/08/009449; date of registration 22/08/2017)
Significant ocular complications following IViT for retinoblastoma are uncommon, and this risk may be reduced further by the use of careful injection technique and standard dosing regimens. Care must be taken in the dosing of intravitreal treatments to avoid potentially irreversible vision loss.
Purpose To report a diplopia questionnaire (DQ) with a data-driven scoring algorithm. Design Cross-sectional study. Participants To optimize questionnaire scoring: 147 adults with diplopic strabismus completed both the DQ and the Adult Strabismus-20 (AS-20) health-related quality of life (HRQOL) questionnaire. To assess test-retest reliability: 117 adults with diplopic strabismus. To assess responsiveness to surgery: 42 adults (46 surgeries). Methods The 10-item AS-20 function subscale score (scored 0 to 100) was defined as the gold standard for severity. A range of weights was assigned to the responses and to the gaze positions (from equal weighting to greater weighting of primary and reading). Combining all response option weights with all gaze position weights yielded 382,848 scoring algorithms. We then calculated 382,848 Spearman rank correlation coefficients comparing each algorithm with the AS-20 function subscale score. Main outcome measures To optimize scoring, Spearman rank correlation coefficients (measuring agreement) between DQ scores and AS-20 function subscale scores. For test-retest reliability, 95% limits of agreement, and intraclass correlation coefficient (ICC). For responsiveness, change in DQ score. Results For the 382,848 possible scoring algorithms, correlations with AS-20 function subscale score ranged from −0.64 (best correlated) to −0.55. The best-correlated algorithm had response option weights of 5 for rarely, 50 for sometimes, and 75 for often, and gaze position weights of 40 for straight ahead in the distance, 40 for reading, 1 for up, 8 for down, 4 for right, 4 for left, and 3 for other, totaling 100. There was excellent test-retest reliability with an ICC of 0.89 (95% confidence interval 0.84 to 0.92) and 95% limits of agreement were 30.9 points. The DQ score was responsive to surgery with a mean change of 51 ± 34 (p<0.001). Conclusions We have developed a data-driven scoring algorithm for the diplopia questionnaire, rating diplopia symptoms from 0 to 100. Based on correlations with HRQOL, straight ahead and reading positions should be highly weighted. The DQ has excellent test-retest reliability and responsiveness, and may be useful in both clinical and research settings.
Local and systemic tumour spread following IViT in cases of retinoblastoma is rare, and this risk is potentially reduced by the use of safety enhancing injection techniques. These results suggest that the risk of tumour spread should not preclude IViT use for carefully selected patients as part of multi-modal globe salvaging therapy.
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