Sample Size for Oxidative Stress and Inflammation When Treating Multiple Sclerosis with Interferon-β1a and Coenzyme Q10

Abstract

Studying multiple sclerosis (MS) and its treatments requires the use of biomarkers for underlying pathological mechanisms. We aim to estimate the required sample size for detecting variations of biomarkers of inflammation and oxidative stress. This is a post-hoc analysis on 60 relapsing-remitting MS patients treated with Interferon-β1a and Coenzyme Q10 for 3 months in an open-label crossover design over 6 months. At baseline and at the 3 and 6-month visits, we measured markers of scavenging activity, oxidative damage, and inflammation in the peripheral blood (180 measurements). Variations of laboratory measures (treatment effect) were estimated using mixed-effect linear regression models (including age, gender, disease duration, baseline expanded disability status scale (EDSS), and the duration of Interferon-β1a treatment as covariates; creatinine was also included for uric acid analyses), and were used for sample size calculations. Hypothesizing a clinical trial aiming to detect a 70% effect in 3 months (power = 80% alpha-error = 5%), the sample size per treatment arm would be 1 for interleukin (IL)-3 and IL-5, 4 for IL-7 and IL-2R, 6 for IL-13, 14 for IL-6, 22 for IL-8, 23 for IL-4, 25 for activation-normal T cell expressed and secreted (RANTES), 26 for tumor necrosis factor (TNF)-α, 27 for IL-1β, and 29 for uric acid. Peripheral biomarkers of oxidative stress and inflammation could be used in proof-of-concept studies to quickly screen the mechanisms of action of MS treatments.

The Use of Antioxidants in the Treatment of Migraine

“…Coenzyme Q10 is a relevant element in the respiratory chain, where it acts as an electron carrier [74]. Due to its potential positive effects, it is considered as a dietary supplement in numerous diseases of the nervous system, for example, in neurodegenerative diseases (Parkinson's diseases, amyotrophic lateral sclerosis (ALS), Friedreich's ataxia) and in multiple sclerosis (MS) [71,75].…”

Low Antioxidant Status of Serum Uric Acid, Bilirubin, Albumin, and Creatinine in Patients With Benign Paroxysmal Positional Vertigo

“…UA is a naturally occurring product of purine metabolism and is known as a strong scavenger of peroxynitrite. In addition, UA acts as a protective antioxidant in neurodegenerative diseases, such as Parkinson's disease (19), Guillain-Barre syndrome (20), multiple sclerosis (21), and amyotrophic lateral sclerosis (22). However, there is no consensus whether UA is a protective or risk factor for BPPV.…”

Advances in Multiple Sclerosis Research–Series I

“…Measuring biomarkers of inflammation and oxidative stress is important to understand the efficacy of treatments. As such, Moccia et al studied 60 patients with RRMS who were treated with IFN beta-1a or Coenzyme Q10 and monitored patients for IL-1b, IL-2R, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-13, RANTES, tumor necrosis factor and uric acid (Figure 1) [33]. These serum biomarkers could be used to determine the efficacy of treatments as well as their mechanisms of action.…”