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A Case Study of L-Carnosine for Patient-Reported Outcomes and Brain Metabolism in Multiple Sclerosis

ABSTRACT: Abstract Objectives This case trial reports the effects of L-carnosine supplementation on neuromuscular performance, brain metabolism, and various patient- and clinician-reported outcomes in a case series of patients with multiple sclerosis (MS). Methods Two women (aged 37 and 48) and a man (age 48 years) who fulfilled the 2017 McDonald criteria for MS diagnosis, and were free of other major chronic diseases or acute disorders were recruited for this case study. The duration of illness was 4 years in CASE 1 (37-year old women), 5 years in CASE 2 (48-year old men), and 15 years in CASE 3 (48-year old women). L-carnosine (2 g/day) was administered orally during 8 weeks in all MS patients. The trial was registered at ClinicalTrials.gov (ID NCT03995810). Results The intensity of symptoms and signs of MS after L-carnosine administration diminished in 5 out of 7 domains in CASE 1, in 3 out of 7 domains in CASE 2, and one domain in CASE 3; general fatigue has been reduced in all three cases at the follow-up. The Visual Analog Scale scores for numbness, weakness, pain, and depression decreased in all MS patients at post-administration. This was accompanied by an improved walking distance to exhaustion in all patients, with values improved for 51.1% in CASE 1, 19.5% in CASE 2, and 2.1% in CASE 3 at 8-week follow-up. An increase in serum total antioxidant capacity was found at 8-week follow-up in all patients (from 4.6 to 49.6%); this was accompanied by lower blood lactates at follow-up in all cases (23.5% on average). Single-voxel 1.5 T MRS revealed an increased brain choline-contained compounds (18.9% on average), total creatine (21.2%), and myo-inositol levels (12.3%) in girus cinguli at 8-week follow; this was accompanied by a drop in brain glutamate for 22.6% on average. Conclusions This case report suggests the favorable effects of medium-term L-carnosine as a possible adjuvant treatment to improve selected patient- and clinician-reported outcomes in a man and two women suffering from MS. There is a need for larger and more rigorous human intervention studies to corroborate these preliminary findings. Funding Sources This study was funded by the Serbian Ministry of Education, Science and Technological Development (#175,037); the Provincial Secretariat for Higher Education and Scientific Research (#114–451-710); the Faculty of Sport and Physical Education, Novi Sad; and CarnoMed LLC, Novi Sad.

SUBMITTER: Ostojic S

PROVIDER: S-EPMC7258284 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Project description:BackgroundThere is increasing emphasis on using patient-reported outcomes (PROs) to complement traditional clinical outcomes in medical research, including in multiple sclerosis (MS). Research, particularly in oncology and heart failure, has shown that PROs can be prognostic of hard clinical endpoints such as survival time (time from study entry until death). However, unlike in oncology or cardiology, it is unknown whether PROs are associated with survival time in neurological diseases. The Multiple Sclerosis Impact Scale-29 (MSIS-29) is a PRO sensitive to short-term change in MS, with questions covering both physical and psychological quality of life. This study aimed to investigate whether MSIS-29 scores can be prognostic for survival time in MS, using a large observational cohort of people with MS.Methods and findingsFrom 15 July 2004 onwards, MSIS-29 questionnaires were completed by people with MS registered with the MS Society Tissue Bank (n = 2,126, repeated 1 year later with n = 872 of the original respondents). By 2014, 264 participants (12.4%) had died. Higher baseline MSIS-29 physical (MSIS-29-PHYS) score was associated with reduced survival time (subgroup with highest scores versus subgroup with lowest scores: hazard ratio [HR] 5.7, 95% CI 3.1-10.5, p < 0.001). Higher baseline MSIS-29 psychological score was also associated with reduced survival time (subgroup with highest scores versus subgroup with lowest scores: HR 2.8, 95% CI 1.8-4.4, p < 0.001). In those with high baseline MSIS-29 scores, mortality risk was even greater if the MSIS-29 score worsened over 1 year (HR 2.3, 95% CI 1.2-4.4, p = 0.02). MSIS-29-PHYS scores were associated with survival time independent of age, sex, and patient-reported Expanded Disability Status Scale score in a Cox regression analysis (per 1-SD increase in MSIS-29-PHYS score: HR 1.8, 95% CI 1.1-2.9, p = 0.03). A limitation of the study is that this cohort had high baseline age and disability levels; the prognostic value of MSIS-29 for survival time at earlier disease stages requires further investigation.ConclusionsThis study reports that PROs can be prognostic for hard clinical outcomes in neurological disease, and supports PROs as a meaningful clinical outcome for use in research and clinical settings.

Project description:BackgroundTreatment and monitoring decisions in people with multiple sclerosis (MS) are based commonly on clinician-reported outcomes. These reflect physical and radiological disease activity and are the most relevant endpoints in clinical trials. Over the past few years, the number of studies evaluating so-called patient-reported outcomes (PROs) has been increasing. PROs are reports from patients concerning their own health perception. They are typically obtained by means of questionnaires and aim to quantify symptoms such as fatigue, depression, and sexual dysfunction. The emergence of PROs has made a tremendous contribution to understanding the individual impact of disease in people with MS and their health-related quality of life. However, the assessment of PROs consumes resources, including time and personnel. Thus, useful ways to conveniently introduce PROs into clinical practice are needed.ObjectiveWe aim to provide a rationale and pilot study protocol for a mobile health (mHealth) solution named "haMSter" that allows for remote monitoring of PROs in people with MS.MethodsThe core function of haMSter is to provide three scientifically validated PRO questionnaires relevant to MS for patients to fill out at home once a month. Thereby, longitudinal and remote documentation of PROs is enabled. A scoring algorithm graphically plots PRO scores over time and makes them available at the next visit.ResultsThe pilot study is currently ongoing and will evaluate adherence to this mHealth solution in 50 patients over a period of 6 months. Results from the haMSter pilot study are expected in 2021.ConclusionshaMSter is a novel mHealth-based solution for modern PRO research, which may constitute the first step in achieving the ability to integrate PROs in clinical practice. This allows for a more problem-oriented approach in monitoring visits, which addresses patient needs and ultimately saves time.Trial registrationClinicalTrials.gov NCT04555863; https://clinicaltrials.gov/ct2/show/NCT04555863.International registered report identifier (irrid)DERR1-10.2196/25011.

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A Case Study of L-Carnosine for Patient-Reported Outcomes and Brain Metabolism in Multiple Sclerosis

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