1.
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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Plain language summary
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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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.
A Randomized Controlled Trial of Fasting and Lifestyle Modification in Patients with Metabolic Syndrome: Effects on Patient-Reported Outcomes.
Jeitler, M, Lauche, R, Hohmann, C, Choi, KA, Schneider, N, Steckhan, N, Rathjens, F, Anheyer, D, Paul, A, von Scheidt, C, et al
Nutrients. 2022;14(17)
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Plain language summary
The metabolic syndrome (MetS) is a condition characterized by the presence of at least three cardiovascular risk factors, such as abdominal obesity, hypertension, insulin resistance, and dyslipidaemia. The aim of this study was to assess effects of fasting followed by the Mind-Body Medicine in Integrative and Complementary Medicine (MICOM) lifestyle modification intervention in patients with MetS on patient-reported outcomes, compared to a lifestyle modification intervention only. This study is a single-blind, bicentre, randomized controlled study. Patients (n=145) were randomly assigned in a 1:1 ratio into one of the 2 groups: fasting and lifestyle modification or the lifestyle modification. They started with 2 vegan days (max. 1200 kcal/day), followed by 5 days of fasting (max. 350 kcal/day), and a stepwise reintroduction of food. Then they participated in the 10-week MICOM comprehensive multimodal lifestyle modification intervention with weekly 6-h sessions. Results show that after the multimodal lifestyle modification intervention, there were improvements for all outcome measures, namely quality of life, anxiety, depression, stress, mood as well as self-efficacy, mindfulness, and self-compassion, which persisted at the follow-up after 24 weeks. Authors conclude that their findings show beneficial and clinically relevant effects of fasting and intensified lifestyle modification on quality of life and psychological parameters.
Expert Review
Conflicts of interest:
None
Take Home Message:
For clients with Metabolic syndrome a 5-day fast consisting of max. 350 kcal/day, in conjunction with therapies that focus on improved emotional, mental, social, spiritual, and behavioural factors may directly affect health and support improved mood.
Therapies include mindfulness and specific group training rooted in psycho-neuroendocrinology, and the use of formal meditation and gentle yoga exercises. As well as nutritional education included lectures, cooking workshops, as well as group support.
Bottom line: The use of complimentary therapies such as mindfulness, yoga and medication in conjunction with nutritional advice and may be effective to support improved mood in clients with Metabolic syndrome.
Evidence Category:
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X
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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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:
Metabolic syndrome (MetS) is a condition characterised by the presence of at least three cardiovascular risk factors such as abdominal obesity, hypertension, insulin resistance, and dyslipidemia.
The authors refer to epidemiological studies that have identified the role of psychological risk factors such as psychosocial stress, depression and anxiety in patients with MetS and cardiovascular disease.
This single-blind, bi-centre RCT assessed the effects of fasting followed by a comprehensive lifestyle modification program MICOM (Mind-Body Medicine in Integrative and Complementary Medicine) in 145 participants with Metabolic Syndrome (MetS) (62.8% women; 59.7 ± 9.3 years) randomised to:
1. 5-day fasting followed by 10 weeks of lifestyle modification (F + LM; modified DASH diet, exercise, mindfulness; n = 73) or
2. 10 weeks of lifestyle modification only (LM; n = 72)
The study duration was 24 weeks occurring from April 2014 to December 2014, with the last follow-up assessment in December 2015. 73 Participants were randomised into an F + LM group and 72 participants into an LM group between the ages of 59 and 60.
Outcomes were assessed at weeks 0, 1, 12, and 24, for quality of life (Short-Form 36 Health Survey Questionnaire, SF-36), anxiety/depression (Hospital Anxiety and Depression Scale, HADS), stress (Cohen Perceived Stress Scale, CPSS), mood (Profile of Mood States, POMS), self-efficacy (General Self-Efficacy Scale, GSE), mindfulness (Mindfulness Attention Awareness Scale, MAAS), and self-compassion (Self-Compassion Scale, SCS).
At week 1, POMS depression and fatigue scores were significantly lower in F + LM compared to LM. At week 12, most self-report outcomes improved in both groups—only POMS vigour was significantly higher in F + LM than in LM. Most of the beneficial effects within the groups persisted at week 24.
Clinical practice applications:
This randomised controlled trial highlights fasting-induced mood-modulating effects in the short term (<24 months).
LM induced several positive effects on quality of life and psychological parameters in participants with MetS.
The compliance rate for this study was good and there were no adverse effects reported suggesting a potentially effective lifestyle modification intervention for adults with metabolic syndrome.
The authors did note the extent to which participants adhered to the program by using stress reduction techniques at home was not assessed.
Considerations for future research:
MBM lifestyle modification intervention led to an improvement of self-efficacy, mindfulness, and self-compassion.
Further studies to explore explanatory models for the effects of MBM are needed.
Mediating variables on mindfulness, self-efficacy, and compassion, and the effects on physical and psychological parameters, need to be examined more closely.
Future studies could use condition-specific questionnaires in addition to generic ones, which have previously been used to facilitate the comparison of the study results with those in the population.
Abstract
Lifestyle interventions can have a positive impact on quality of life and psychological parameters in patients with metabolic syndrome (MetS). In this randomized controlled trial, 145 participants with MetS (62.8% women; 59.7 ± 9.3 years) were randomized to (1) 5-day fasting followed by 10 weeks of lifestyle modification (F + LM; modified DASH diet, exercise, mindfulness; n = 73) or (2) 10 weeks of lifestyle modification only (LM; n = 72). Outcomes were assessed at weeks 0, 1, 12, and 24, and included quality of life (Short-Form 36 Health Survey Questionnaire, SF-36), anxiety/depression (Hospital Anxiety and Depression Scale, HADS), stress (Cohen Perceived Stress Scale, CPSS), mood (Profile of Mood States, POMS), self-efficacy (General Self-Efficacy Scale, GSE), mindfulness (Mindfulness Attention Awareness Scale, MAAS), and self-compassion (Self-Compassion Scale, SCS). At week 1, POMS depression and fatigue scores were significantly lower in F + LM compared to LM. At week 12, most self-report outcomes improved in both groups-only POMS vigor was significantly higher in F + LM than in LM. Most of the beneficial effects within the groups persisted at week 24. Fasting can induce mood-modulating effects in the short term. LM induced several positive effects on quality of life and psychological parameters in patients with MetS.