Effectiveness of Yoga Intervention in Reducing Felt Stigma in Adults With Epilepsy: A Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: Persons with epilepsy are afflicted with comorbidities such as stigma, anxiety, and depression which have a significant impact on their quality of life. These comorbidities remain largely unaddressed in resource-limited countries. This randomized controlled trial (RCT) aimed to investigate whether yoga and psychoeducation were effective in reducing felt stigma (primary outcome), neuropsychiatric outcomes, and seizure frequency, as compared with sham yoga and psychoeducation in persons with epilepsy. METHODS: This was an assessor-blinded, sham yoga-controlled RCT. Patients clinically diagnosed with epilepsy, aged 18-60 years, and scoring higher than the cutoff score for felt stigma as measured by the Kilifi Stigma Scale (KSS) in our population were randomly assigned to receive either yoga therapy plus psychoeducation (intervention) or sham yoga therapy plus psychoeducation (comparator) for a duration of 3 months. The primary outcome was a significant decrease in felt stigma as compared with the comparator arm as measured by the KSS. Primary and secondary outcomes (seizure frequency, quality of life, anxiety, depression, mindfulness, trait rumination, cognitive impairment, emotion regulation) were assessed at baseline, 3 months, and 6 months. Parametric/nonparametric analysis of covariance and the χ2 test were used to compare the 2 arms. RESULTS: A total of 160 patients were enrolled in the trial. At the end of the follow-up period (6 months), the intervention arm reported significant reduction in felt stigma as compared with the control arm (Cohen's d = 0.23, 95% CI -0.08 to 0.55, p = 0.006). Significantly higher odds of >50% seizure reduction (odds ratio [OR] 4.11, 95% CI 1.34-14.69, p = 0.01) and complete seizure remission (OR 7.4, 95% CI 1.75-55.89, p = 0.005) were also observed in the intervention group. The intervention group showed significant improvement in symptoms of anxiety, cognitive impairment, mindfulness, and quality of life relative to the control group at the end of follow-up period (p < 0.05). DISCUSSION: Yoga can alleviate the burden of epilepsy and improve the overall quality of life in epilepsy by reducing perceived stigma. TRIAL REGISTRATION INFORMATION: Clinical Trials Registry of India (CTRI/2017/04/008385). CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that yoga reduces felt stigma in adult patients with epilepsy.

Antioxidants for Pancreatic Functions in Chronic Pancreatitis: A Double-blind Randomized Placebo-controlled Pilot Study.

BACKGROUND: Antioxidants (AO) supplementation in chronic pancreatitis (CP) has been evaluated for pain. But it is not clear whether AO in CP have an effect on pancreatic functions and other clinical outcomes. We evaluated effect of AO on endocrine function in CP. MATERIALS AND METHODS: Double-blind placebo (PL)-controlled randomized pilot study on 107 patients with CP assigned to receive daily combined AO or PL for 6 months. Primary outcome was: improvement in endocrine function (Homeostasis Model Assessment-Insulin Resistance). Secondary outcome measures were: improvement in C-peptide, Qualitative Insulin Sensitivity Check Index, exocrine pancreatic function (fecal elastase), surrogate markers of fibrosis (platelet-derived growth factor BB, transforming growth factor-ß1, α-smooth muscle actin), quality of life (QOL), pain, nutritional status, markers of oxidative stress (OS), AO status, and inflammation. RESULTS: There was an increase in levels of serum selenium (107.2±26.9 to 109.7±26.9 vs. 104.1±28.6 to 124.0±33.6 µg/L, P=0.022) and serum vitamin E [0.58 (range, 0.27-3.22) to 0.66 (range, 0.34-1.98) vs. 0.63 (range, 0.28-1.73) to 1.09 (range, 0.25-2.91) mg/dL, P=0.001] in the AO than the PL group. However, no significant differences were observed between groups in any of the primary or secondary outcome measures. CONCLUSIONS: Supplementation with AO to patients with CP causes a sustained increase in blood levels of AO; however, it has no addition benefit over PL on endocrine and exocrine functions, markers of fibrosis, OS and inflammation, nutritional status, pain and QOL. Further larger studies with adequate sample size are required.