Efficacy and Safety of Q10 Ubiquinol With Vitamins B and E in Neurodevelopmental Disorders: A Retrospective Chart Review.

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• Oxidative stress and mitochondrial dysfunction are reported to play a role in brain and neurological disorders.
• This retrospective chart review suggests that metabolic support therapy with Q10 ubiquinol, vitamin E and complex-B vitamins is well tolerated and produces some improvement in most patients with neurodevelopmental disorders, especially in the presence of intellectual disability.

Introduction

A retrospective chart review study was conducted on the clinical efficacy and safety of metabolic support therapy (MST) with Q10 ubiquinol, vitamin E and complex-B vitamins in various neurodevelopmental disorders.

59 patients (49 Children and 6 Adults) between the ages of 2.5–39 years old diagnosed with Autism Spectrum Disorder (n=17), Autism Spectrum Disorder with co-morbid Intellectual Disability (n=19), Intellectual Disability or Global Developmental Delay (n=15), Attention-Deficit/Hyperactivity Disorder (n=3), and Intellectual Disability in Phelan-McDermid syndrome due to chr. 22q13.33 deletions (n=5) were included in the study.

Methods

Participants received 50-100mg Q10 ubiquinol, 30-60mg of vitamin E, 5.5mg-11mg of nicotinamide, 3mg-6mg of dexpanthenol, 0.45mg-0.09mg of riboflavin-5’-sodium phosphate, 5mg-10mg of inositol, pyridoxine hydrochloride, and 0.07mcg -1.40mcg of cyanocobalamin for three months. Different dosage levels were administered based on the participant’s body weight and the maximum daily allowance stated by Italy’s Ministry of Health. Patients remained on their prescribed antipsychotic medications during the study.

The Clinical Global Impression of Severity (CGI-S) scale, as well as the Clinical Global Impression of Improvement (CGI-I) scale was assessed by experienced Child and Adolescent or Adult Psychiatrists.

The clinical diagnosis was further confirmed using the Autism Diagnostic Observation Schedule – 2nd ed (ADOS-2) and the Autism Diagnostic Interview-Revised (ADIR) for ASD, the Griffiths Mental Development Scale (GMDS) for GDD, a cognitive test (Leiter-R,WPPSI-III,WISC-IV,WAISIV) for ID, the Conners Parent Rating Scale (CPRS) also in Teacher version (TRF) and the Batteria Italiana per l’ADHD (BIA) for ADHD.

At the endpoint, 45/59 (76.2%) of the subjects completed the study. No reasons were given for dropouts.

Results

Primary clinical outcomes were:

• Most widespread improvements were recorded in cognition (n=26 44,1%), adaptive functioning (n=26 44,1%) and social motivation (n=19 32.2%).
• Based on clinical chart reviews 45/59 (76.27%) patients responded to MST according to Clinical Global Impression of Severity scores.
• One 13-year-old boy with an intellectual disability, gained over 20 IQ points after consuming metabolic support therapy for 6 months.
• Mild side effects of hyperactivity and insomnia were reported in 18/59 (30%) of patients.

• Pharmacological treatments are prescribed to correct comorbid symptoms like sleep disorders, aggressiveness, and irritability in neurodevelopmental disorders like ASD. The efficacy of these treatments displays great interindividual variability depending not only on the treatment approach, therapist experience, and therapeutic setting but also on the genetic background of the patient.
• Oxidative stress and mitochondrial dysfunction have been described in many different brain and neurological disorders.
• Minimising the mitochondrial dysfunction produced by oxidative stress damage in brain disorders, while not directly correcting the primary mechanism responsible for the pathology, may nonetheless help to improve the clinical condition, acting as an indirect therapy.
• This study provides preliminary evidence of the efficacy and tolerability of a ‘metabolic support therapy’ encompassing Q10- ubiquinol, Vitamin E and complex-B vitamins in patients with different neurological disorders.

• This study was based on a retrospective design using a small sample size.
• Randomised controlled trials for each single neurodevelopmental disorder are needed to conclusively demonstrate the efficacy of these mitochondrial bioenergetic and antioxidant agents and to estimate their therapeutic effect size.