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Efficacy and Safety of Q10 Ubiquinol With Vitamins B and E in Neurodevelopmental Disorders: A Retrospective Chart Review.
Cucinotta, F, Ricciardello, A, Turriziani, L, Mancini, A, Keller, R, Sacco, R, Persico, AM
Frontiers in psychiatry. 2022;13:829516
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The literature shows that oxidative stress represents a shared feature present in many brain disorders and more specifically in neurodevelopmental disorders (NDDs) including autism spectrum disorder, attention-deficit/hyperactivity disorder, and intellectual disability. The aim of this study was to verify retrospectively the clinical efficacy and safety of a metabolic support therapy (MST) with coenzyme Q10 (Q10 ubiquinol), vitamin E and complex-B vitamins in various neurodevelopmental disorders. This study is a retrospective chart review of 59 patients with NDDs. Results show that in terms of efficacy, MST was associated with clinical improvement in 45/59 (76.27%) patients. Whereas in terms of safety, side effects were mild and always manageable. Thus, this study provides retrospective evidence of efficacy and tolerability for a MST encompassing Q10-ubiquinol, vitamin E and complex-B vitamins in patients with different neurodevelopmental disorders. Authors conclude that their findings encourage further investigations of MST efficacy in neurodevelopmental disorders in order to confirm the generalisability of the study’s observations, verifying both efficacy, safety, treatment response rates and therapeutic effect size, separately in each major neurodevelopmental disorder.
Expert Review
Conflicts of interest:
None
Take Home Message:
- 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.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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X
C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
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.
Clinical practice applications:
- 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.
Considerations for future research:
- 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.
Abstract
Increased oxidative stress and defective mitochondrial functioning are shared features among many brain disorders. The aim of this study was to verify retrospectively the clinical efficacy and safety of a metabolic support therapy with Q10 ubiquinol, vitamin E and complex-B vitamins in various neurodevelopmental disorders. This retrospective chart review study included 59 patients (mean age 10.1 ± 1.2 y.o., range 2.5-39 years; M:F = 2.47:1), 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 deletion (n = 5). After a minimum of 3 months of therapy, a positive outcome was recorded in 45/59 (76.27%) patients, with Clinical Global Impression-Improvement scores ranging between 1 ("very much improved") and 3 ("minimally improved"). The most widespread improvements were recorded in cognition (n = 26, 44.1%), adaptative functioning (n = 26, 44.1%) and social motivation (n = 19, 32.2%). Improvement rates differed by diagnosis, being observed most consistently in Phelan-McDermid Syndrome (5/5, 100%), followed by Intellectual Disability/Global Developmental Delay (13/15, 86.7%), Autism Spectrum Disorder with co-morbid Intellectual Disability (15/19, 78.9%), Autism Spectrum Disorder (11/17, 64.7%) and ADHD (1/3, 33.3%). No significant adverse event or side effect leading to treatment discontinuation were recorded. Mild side effects were reported in 18 (30.5%) patients, with the most frequent being increased hyperactivity (9/59, 15.3%). 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 the majority of patients with neurodevelopmental disorders, especially in the presence of intellectual disability. Randomized controlled trials for each single neurodevelopmental disorder are now warranted to conclusively demonstrate the efficacy of these mitochondrial bioenergetic and antioxidant agents and to estimate their therapeutic effect size.
2.
Effects of Antioxidants on Pain Perception in Patients with Fibromyalgia-A Systematic Review.
Fernández-Araque, A, Verde, Z, Torres-Ortega, C, Sainz-Gil, M, Velasco-Gonzalez, V, González-Bernal, JJ, Mielgo-Ayuso, J
Journal of clinical medicine. 2022;11(9)
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Fibromyalgia (FM) is characterised by widespread chronic pain, fatigue, sleep disturbances, and cognitive impairment. As a result of oxidative stress, reactive oxygen species (ROS) are produced and improperly disposed of, resulting in peripheral and central sensitisations, and a reduction of the pain threshold in FM patients. It is well known that antioxidants are protective against oxidative stress and that reducing antioxidant levels can result in increased pain in patients with FM. An overview of 17 studies was conducted to evaluate the effect of antioxidant supplementation on pain perception and the appropriate duration of treatment for FM patients in this systematic review. This systematic review found that supplementation with Fibromyalgine® (Fib) (that contains vitamin C, acerola ginger root, and freeze-dried royal jelly), 300-400 gm/d of coenzyme Q10 alone in combination with Pregabalin, ferric carboxymaltose, vitamin C, E, and Nigella sativa, magnesium + amitriptyline, acetyl L-carnitine, and Sun Chlorella™ green algae are effective in reducing pain perception in FM patients. In patients with FM, alpha-lipoic acid supplementation significantly reduced pain scores. 80% of FM patients reported reduced pain after supplement treatment for at least six weeks. There is a need for further robust long-term studies to confirm the effectiveness and clinical applicability of antioxidants in the management of FM, as well as to identify the pathophysiology of FM. This research may, however, be used by healthcare professionals to gain a better understanding of the potential benefits of antioxidants in the treatment of pain associated with FM.
Abstract
In recent years, antioxidant supplements have become popular to counteract the effects of oxidative stress in fibromyalgia and one of its most distressing symptoms, pain. The aim of this systematic review was to summarize the effects of antioxidant supplementation on pain levels perceived by patients diagnosed with fibromyalgia. The words used respected the medical search terms related to our objective including antioxidants, fibromyalgia, pain, and supplementation. Seventeen relevant articles were identified within Medline (PubMed), Scopus, Web of Science (WOS), the Cochrane Database of Systematic Review, and the Cochrane Central Register of Controlled Trials. This review found that antioxidant supplementation is efficient in reducing pain in nine of the studies reviewed. Studies with a duration of supplementation of at least 6 weeks showed a benefit on pain perception in 80% of the patients included in these studies. The benefits shown by vitamins and coenzyme Q10 are remarkable. Further research is needed to identify the effects of other types of antioxidants, such as extra virgin olive oil and turmeric. More homogeneous interventions in terms of antioxidant doses administered and duration would allow the effects on pain to be addressed more comprehensively.