Vitamins C and D and COVID-19 Susceptibility, Severity and Progression: An Evidence Based Systematic Review.

Background and Objectives: Starting in early December 2019, the novel Coronavirus Disease (COVID-19) from infection with COVID-19 has caused a global pandemic. Many aspects of its pathogenesis and related clinical consequences are still unclear. Early diagnosis and dynamic monitoring of prognostic factors are essential to improve the ability to manage COVID-19 infection. This study aimed to provide an account of the role played by vitamins C and D on the onset, progression and severity of COVID-19. Clinical features and infection-related risk factors are also briefly discussed. Material and Methods: In March 2022, the main online databases were accessed. All the articles that investigate the possible role of vitamins C and D on COVID-19 susceptibility, severity and progression were considered. Results: The current evidence on vitamin C and D supplementation in patients with COVID-19 infection is inconsistent and controversial. In some studies, vitamins were used as coadjuvant of a formal experimental therapy, while in others as main treatment. Ethnicity and hospital setting (inpatient/outpatient) were also variable. Moreover, there was no consensus between studies in administration protocol: high heterogeneity in dosage, administration, and duration of the treatment were evident. Finally, some studies administered vitamins pre- and/or during COVID infection, in patients with different risk factors and infection severity. Conclusions: While waiting to develop a targeted, safe and effective therapy, it is important to investigate individual predisposition and proper disease management. Concluding, available data on the use of nutraceuticals in COVID-19 are inconsistent. However, there is a lack of evidence-based guidelines which recommend vitamin C and D supplementation in patients with COVID-19, and results from high quality randomised controlled trials (RCTs) are inconsistent. Current investigations so far are mostly observational, and include a relatively small sample size which can lead to biased results. Large-scale multicentre studies are therefore needed.

The Neural Signature of Psychological Interventions in Persons With Cancer: A Scoping Review.

OBJECTIVE: People diagnosed with cancer have to deal with the debilitating psychological implications of this disease. Although the clinical efficacy of psychological interventions is well documented, relatively little has been written on the neural correlates of these treatments in the context of oncology. The present work is the first to provide an overall perspective of the existing literature on this topic. It also considers the potential directions for future research. METHODS: This scoping review was carried out across 5 databases (EMBASE, PsycINFO, OVID MEDLINE, CINAHL, COCHRANE CENTRAL), from conception dates until 3 December 2021. RESULTS: From an initial set of 4172 records, 13 papers were selected for this review. They consisted of 9 randomized controlled studies (RCTs), 1 quasi-experiment, 2 single case studies, and 1 secondary quantitative analysis. The studies were also heterogeneous in terms of the patient and control populations, psychological interventions, and neuroimaging methodologies used. The findings from these few studies suggest that psychological interventions in oncology patients may modulate both cortical and subcortical brain activity, consistent with the brain areas involved in distress reactions in general and to cancer specifically. The implications of this scoping review in terms of future research are also discussed. CONCLUSIONS: The literature on the neural correlates of psychological interventions in cancer patients is very limited, and thus requires further exploration. The provision of psychological interventions offers cancer patients a more integrated approach to care, which may in turn help preserve both the physical and the psychological wellbeing of individuals with cancer.

The efficacy of mindfulness-based interventions in attention-deficit/hyperactivity disorder beyond core symptoms: A systematic review, meta-analysis, and meta-regression.

BACKGROUND: Mindfulness-Based Interventions (MBIs) have been increasingly proposed as treatment in patients with Attention-Deficit/Hyperactivity Disorder (ADHD), showing promising results on different proposed outcomes, in both children and adults. OBJECTIVES: To systematically review and meta-analyse studies concerning the effects of MBIs on either ADHD and associated features, associated clinical conditions, neurocognitive impairments, mindfulness skills, global functioning and quality of life. METHODS: Searches were conducted on five databases, including controlled and observational studies on both adults and children populations. The review process was compliant to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). Meta-analyses and meta-regression models were conducted. RESULTS: Thirty-one full-texts were included. In both adults and children, MBIs showed to be more effective than waiting lists in improving ADHD symptoms and some other outcomes. In adults, a medium pooled effect size was shown by meta-analysis for ADHD symptoms but in some cases a publication bias was detected. Subgroup analysis and meta-regression confirmed the gap detected by our systematic review between the medium/large effect size of inactive-controlled studies and the low/negligible one of active-controlled studies. In children, no active-controlled studies have been conducted. Mindfulness Awareness Practice (MAP) and Mindfulness Based Cognitive Therapy (MBCT) were the most used protocols in adult studies, whereas a combination of MBCT and Mindfulness Based Stress Reduction (MBSR) was more preferred for children and adolescent patients. CONCLUSIONS: Even if further studies with a better methodology are needed, we can suggest the MBIs may be useful as complementation and not as replacement of other active interventions.

Eye movement desensitization and reprocessing for depression: a systematic review and meta-analysis.

Background: In recent years, eye movement desensitization and reprocessing (EMDR) has been applied to different psychiatric conditions beyond post-traumatic stress disorder (PTSD), and an increasing number of studies have evaluated its effect on depression. To date, no quantitative synthesis of the efficacy of EMDR on depression has been conducted. Objective: To meta-analytically review the studies on EMDR for depression as the primary target for treatment. Method: Studies with a controlled design evaluating the effect of EMDR on depression were searched on six electronic databases (PubMed, Embase, CINAHL, PsycINFO, Cochrane database, and Francine Shapiro Library) and then selected by two independent reviewers. A systematic review and meta-analysis was conducted. Results: Eleven studies were included for qualitative synthesis. Nine studies were included in the meta-analysis, involving 373 participants. The overall effect size of EMDR for depressive symptoms is large (n = 9, Hedges' g = - 1.07; 95%CI [-1.66; - 0.48]), with high heterogeneity (I 2 = 84%), and corresponds to a 'number needed to treat' of 1.8. At follow-up (range 3-6 months), the effect remains significant but moderate (n = 3, Hedges' g = - 0.62; 95%CI [-0.97; - 0.28]; I 2 = 0%). The effect of EMDR compared with active controls is also moderate (n = 7, g = - 0.68; 95%CI [-0.92; - 0.43]; I 2 = 0%). No publication bias was found, although the results are limited by the small number and poor methodological quality of the included studies. Conclusions: Review findings suggest that EMDR may be considered an effective treatment for improving symptoms of depression, with effects comparable to other active treatments. However, findings need to be interpreted in light of the limited number of the studies and their quality. Further research is required to understand the longer-term of effects EMDR in treating depression and preventing depression relapse. Protocol registration: PROSPERO (CRD42018090086).

Antecedentes: En los últimos años, la desensibilización y reprocesamiento por movimientos oculares (EMDR) se ha aplicado a diferentes condiciones psiquiátricas más allá del trastorno de estrés postraumático (TEPT), y un número creciente de estudios ha evaluado su efecto en la depresión. Hasta la fecha, no se ha realizado ninguna síntesis cuantitativa de la eficacia de la EMDR en la depresión.Objetivo: Revisar meta-analíticamente los estudios de EMDR para la depresión como objetivo principal del tratamiento.Método: Se buscaron estudios con un diseño controlado que evaluaran el efecto de la EMDR en la depresión en seis bases de datos electrónicas (PubMed, Embase, CINAHL, PsycINFO, base de datos Cochrane y Francine Shapiro Library) y luego fueron seleccionados por dos revisores independientes. Se realizó una revisión sistemática y un metanálisis.Resultados: Se incluyeron once estudios para la síntesis cualitativa. Se incluyeron nueve estudios en el meta-análisis, con 373 participantes. El tamaño del efecto global de la EMDR para los síntomas depresivos es grande (n = 9, g de Hedges = −1,07; IC del 95% [−1,66; −0,48]), con alta heterogeneidad (I 2 = 84%), y corresponde a un 'número necesario a tratar' de 1,8. En el seguimiento (rango 3-6 meses), el efecto sigue siendo significativo pero moderado (n = 3, g de Hedges = −0,62; IC del 95% [−0,97;-0,28]; I 2 = 0%). El efecto del EMDR en comparación con los controles activos también es moderado (n = 7, g = −0,68; IC del 95% [−0,92;-0,43]; I 2 = 0%). No se encontró ningún sesgo de publicación, aunque los resultados están limitados por el pequeño número y la pobre calidad metodológica de los estudios incluidos.Conclusiones: Los resultados de la revisión sugieren que la EMDR puede considerarse un tratamiento eficaz para mejorar los síntomas de la depresión, con efectos comparables a los de otros tratamientos activos. Sin embargo, los hallazgos deben interpretarse a la luz del número limitado de los estudios y su calidad. Se requiere investigación adicional para comprender los efectos a largo plazo de la EMDR en el tratamiento de la depresión y la prevención de la recaída de la depresión.Registro del protocolo: PROSPERO (CRD42018090086).

Current pharmacological approaches to the treatment of tendinopathy.

INTRODUCTION: Tendinopathies are common in elite and recreational athletes: traditionally considered overuse injuries, they involve excessive tensile loading and subsequent breakdown of the loaded tendon. Many pharmacological treatments have been proposed for the management of tendinopathy, with no agreement regarding the overall best option available both for Achilles and patellar tendinopathy. AREAS COVERED: The present article reports the best scientific evidence regarding the efficacy and safety of different pharmacological treatments in different types of tendinopathy, focusing on Achilles and patellar tendinopathy, the conditions on which more studies have been published. EXPERT OPINION: No univocal evidence exists regarding the best non-operative management, which includes non-steroidal anti-inflammatory drugs, platelet-rich plasma, high volume image-guided injections, hyaluronic acid, and prolotherapy, for tendinopathy (in particular Achilles and patellar tendinopathies) as a suitable alternative to the commonly used eccentric loading rehabilitation regimen. It is unclear whether the combination of pharmacological substances with physical therapy would produce better results than physical therapy alone. There is an overall lack of published well-performed randomized controlled trials comparing the various options available for the management of tendinopathy, studying large cohorts of patients for adequately long follow-up periods and with well-validated standardized scores and scales.

EMDR in Cancer Patients: A Systematic Review.

Background: Psychological distress is common among patients with cancer, with severe consequences on their quality of life. Anxiety and depression are the most common clinical presentation of psychological distress in cancer patients, but in some cases cancer may represent a traumatic event resulting in posttraumatic stress disorder (PTSD). Currently, Eye Movement Desensitization and Reprocessing (EMDR) therapy is considered an evidence-based treatment for PTSD, but recent studies also showed its effectiveness for anxiety and depression. The aim of the present systematic review is to summarize the current literature on the effect of EMDR on cancer-related psychological distress. Methods: A literature search was conducted for peer-reviewed articles about "EMDR" and "cancer patients" in the following electronic databases: PubMed, MEDLINE, Science Direct, Google Scholar, and Cochrane library. Results: Our search identified 7 studies in which EMDR was used with a total of 140 cancer patients. The psychiatric diagnosis was PTSD in 3 studies. Otherwise, the diagnosis concerned the anxious and depressive disorder spectrum. Overall, EMDR treatment schedules used were highly heterogeneous, with a different number of sessions (from 2 to 12) and a different duration of therapy (up to 4 months). However, across all studies analyzed EMDR therapy was judged to be adequate in reducing symptoms of psychological distress in this population. Conclusions: According to the results of our analysis, the level of evidence regarding EMDR efficacy in cancer patients is limited by the scarcity of studies and their low methodological quality. Although better quality research is needed, available data suggest that EMDR could be a promising treatment for psychological distress in patients with cancer.

Neurobiological features and response to eye movement desensitization and reprocessing treatment of posttraumatic stress disorder in patients with breast cancer.

Background: Breast cancer (BC) is one of the most common invasive types of cancer among women, with important consequences on both physical and psychological functioning. Patients with BC have a great risk of developing posttraumatic stress disorder (PTSD), but few studies have evaluated the efficacy of psychological interventions to treat it. Furthermore, no neuroimaging studies have evaluated the neurobiological effects of psychotherapeutic treatment for BC-related PTSD. Objective: The study aimed to evaluate the efficacy of Eye Movement Desensitization and Reprocessing therapy (EMDR) as compared to Treatment as Usual (TAU) in BC patients with PTSD, identifying by electroencephalography (EEG) the neurophysiological changes underlying treatments effect and their correlation with clinical symptoms. Method: Thirty patients with BC and PTSD diagnosis were included, receiving either EMDR (n = 15) or TAU (n = 15). Patients were assessed before and after treatments with clinical questionnaires and EEG. The proportion of patients who no longer meet criteria for PTSD after the intervention and changes in clinical scores, both between and within groups, were evaluated. Two-sample permutation t-tests among EEG channels were performed to investigate differences in power spectral density between groups. Pearson correlation analysis was carried out between power bands and clinical scores. Results: At post-treatment, all patients treated with EMDR no longer met criteria for PTSD, while all patients treated with TAU maintained the diagnosis. A significant decrease in depressive symptoms was found only in the EMDR group, while anxiety remained stable in all patients. EEG results corroborated these findings, showing significant differences in delta and theta bands in left angular and right fusiform gyri only in the EMDR group. Conclusions: It is essential to detect PTSD symptoms in patients with BC, in order to offer proper interventions. The efficacy of EMDR therapy in reducing cancer-related PTSD is supported by both clinical and neurobiological findings.

Antecedentes: El cáncer de mama (CM) es uno de los tipos de cáncer invasivo más comunes entre las mujeres, con importantes consecuencias tanto en el funcionamiento físico como psicológico. Los pacientes con CM tienen un gran riesgo de desarrollar trastorno de estrés postraumático (TEPT), pero solo unos pocos estudios han evaluado la eficacia de las intervenciones psicológicas para tratarlo. Adicionalmente, ningún estudio de neuroimagen ha evaluado los efectos neurobiológicos del tratamiento psicoterapéutico para el TEPT relacionado con CM. Objetivo: el estudio buscó evaluar la eficacia de la terapia de desensibilización y reprocesamiento con movimientos oculares (EMDR) en comparación con el tratamiento habitual (TAU) en pacientes con TEPT en CM, identificando también mediante EEG los cambios neurofisiológicos que subyacen al efecto de los tratamientos y su correlación con los síntomas clínicos. Método: se incluyeron treinta pacientes con diagnóstico de CM y TEPT, recibiendo EMDR (n = 15) o TAU (n = 15). Los pacientes fueron evaluados antes y después de los tratamientos con cuestionarios clínicos y electroencefalografía (EEG). Se evaluó la proporción de pacientes que dejaron de cumplir con los criterios para trastorno de estrés postraumático después de la intervención y los cambios en las puntuaciones clínicas, tanto al interior como entre los grupos. Se realizaron pruebas t de permutación de dos muestras entre canales EEG para investigar las diferencias en la Densidad del Espectro de Potencia entre los grupos. Se realizó un análisis de correlación de Pearson entre bandas de potencia y puntuaciones clínicas. Resultados: En el postratamiento, todos los pacientes tratados con EMDR ya no cumplían con los criterios para TEPT, mientras que todos los pacientes tratados con TAU mantuvieron el diagnóstico. Se encontró una disminución significativa de síntomas depresivos solo en el grupo EMDR, mientras que la ansiedad se mantuvo estable en todos los pacientes. Los resultados del EEG corroboraron estos hallazgos, mostrando diferencias significativas en las bandas delta y theta en los giros angular izquierdo y fusiforme derecho solo en el grupo EMDR. Conclusiones: es esencial detectar los síntomas de TEPT también en pacientes con CM para poder ofrecer intervenciones adecuadas. La eficacia de la terapia EMDR en reducir el trastorno de estrés postraumático relacionado con el cáncer es apoyado tanto por los hallazgos clínicos como neurobiológicos.

Comparison of Eye Movement Desensitization Reprocessing and Cognitive Behavioral Therapy as Adjunctive Treatments for Recurrent Depression: The European Depression EMDR Network (EDEN) Randomized Controlled Trial.

Background: Treatment of recurrent depressive disorders is currently only moderately successful. Increasing evidence suggests a significant relationship between adverse childhood experiences and recurrent depressive disorders, suggesting that trauma-based interventions could be useful for these patients. Objectives: To investigate the efficacy of Eye Movement Desensitization and Reprocessing therapy (EMDR) in addition to antidepressant medication (ADM) in treating recurrent depression. Design: A non-inferiority, single-blind, randomized clinical controlled trial comparing EMDR or CBT as adjunctive treatments to ADM. Randomization was carried out by a central computer system. Allocation was carried out by a study coordinator in each center. Setting: Two psychiatric services, one in Italy and one in Spain. Participants: Eighty-two patients were randomized with a 1:1 ratio to the EMDR group (n = 40) or CBT group (n = 42). Sixty-six patients, 31 in the EMDR group and 35 in the CBT group, were included in the completers analysis. Intervention: 15 ± 3 individual sessions of EMDR or CBT, both in addition to ADM. Participants were followed up at 6-months. Main outcome measure: Rate of depressive symptoms remission in both groups, as measured by a BDI-II score <13. Results: Sixty-six patients were analyzed as completers (31 EMDR vs. 35 CBT). No significant difference between the two groups was found either at the end of the interventions (71% EMDR vs. 48.7% CBT) or at the 6-month follow-up (54.8% EMDR vs. 42.9% CBT). A RM-ANOVA on BDI-II scores showed similar reductions over time in both groups [F(6,59) = 22.501, p < 0.001] and a significant interaction effect between time and group [F(6,59) = 3.357, p = 0.006], with lower BDI-II scores in the EMDR group at T1 [mean difference = -7.309 (95% CI [-12.811, -1.806]), p = 0.010]. The RM-ANOVA on secondary outcome measures showed similar improvement over time in both groups [F(14,51) = 8.202, p < 0.001], with no significant differences between groups [F(614,51) = 0.642, p = 0.817]. Conclusion: Although these results can be considered preliminary only, this study suggests that EMDR could be a viable and effective treatment for reducing depressive symptoms and improving the quality of life of patients with recurrent depression. TRIAL REGISTRATION: ISRCTN09958202.

The Effectiveness of a Body-Affective Mindfulness Intervention for Multiple Sclerosis Patients with Depressive Symptoms: A Randomized Controlled Clinical Trial.

Purpose: Mindfulness interventions have been shown to treat depressive symptoms and improve quality of life in patients with several chronic diseases, including multiple sclerosis, but to date most evaluation of the effectiveness of mindfulness interventions in multiple sclerosis have used patients receiving standard care as the control group. Hence we decided to evaluate the effectiveness of a group-based body-affective mindfulness intervention by comparing it with a psycho-educational intervention, by means of a randomized controlled clinical trial. The outcome variables (i.e., depression, anxiety, perceived stress, illness perception, fatigue and quality of life) were evaluated at the end of the interventions (T1) and after a further 6 months (T2). Methods: Of 90 multiple sclerosis patients with depressive symptoms (Beck Depression Inventory-II score greater than 13) who were randomized, 71 completed the intervention (mindfulness group n = 36; psycho-educational group n = 35). The data were analyzed with GLM repeated-measures ANOVA followed by pairwise comparisons. Results: Per-protocol analysis revealed a time by group interaction on Beck Depression Inventory-II score, with the mindfulness intervention producing a greater reduction in score than the psycho-educational intervention, both at T1 and at T2. Furthermore, the mindfulness intervention improved patients' quality of life and illness perception at T1 relative to the baseline and these improvements were maintained at the follow-up assessment (T2). Lastly, both interventions were similarly effective in reducing anxiety and perceived stress; these reductions were maintained at T2. A whole-sample intention-to-treat (ITT) analysis broadly confirmed the effectiveness of the mindfulness intervention. Conclusion: In conclusion, these results provide methodologically robust evidence that in multiple sclerosis patients with depressive symptoms mindfulness interventions improve symptoms of depression and anxiety and perceived stress, modulate illness representation and enhance quality of life and that the benefits are maintained for at least 6 months. Trial registration: the study was registered in the ClinicalTrials.gov registry (NCT02611401).

Combined supplementation of ascorbic acid and thyroid hormone T3 affects tenocyte proliferation. The effect of ascorbic acid in the production of nitric oxide.

BACKGROUND: Tissue engineering is now increasingly focusing on cell-based treatments as promising tools to improve tendon repair. However, many crucial aspects of tendon biology remain to be understood before adopting the best experimental approach for cell-tissue engineering. METHODS: The role played by Ascorbic Acid (AA) alone and in combination with thyroid hormone T3 in the viability and proliferation of primary human tendon-derived cells was investigated. Human tenocyte viability was detected by Trypan blue exclusion test and cellular proliferation rate was evaluated by CFSE CellTrace™. In addition, the potential role of the AA in the production of Nitric Oxide (NO) was also examined. RESULTS: In this in vitro model, an increase in tenocyte proliferation rate was observed as a consequence of progressively increased concentrations of AA (from 10 to 50 µg/ml). The addition of the T3 hormone to the culture further increased tenocyte proliferation rate. In detail, the most evident effect on cellular growth was achieved using the combined supplementation of 50 µg/ml AA and 10-7 M T3. CONCLUSION: We showed that the highest concentration of AA (100 and 500 µg/ml) caused cytotoxicity to human tenocytes. Moreover, it was shown that AA reduces NO synthesis. These results show that AA is a cell proliferation inducer that triggers tenocyte growth, while it reduces NO synthesis.

EMDR as Add-On Treatment for Psychiatric and Traumatic Symptoms in Patients with Substance Use Disorder.

Background: Substance use disorders (SUD) are patterns of substance use leading to severe impairment on social, working and economic levels. In vivo and clinical findings have enhanced the role of the brain's stress-related system in maintaining SUD behaviors. Several studies have also revealed a high prevalence of post-traumatic symptoms among SUD patients, suggesting that a trauma-informed treatment approach could lead to better treatment outcomes. However, only few studies have evaluated the use of eye movement desensitization and reprocessing (EMDR) in SUD without consistent results. The aim of the present pilot study was to assess the efficacy of a combined trauma-focused (TF) and addiction-focused (AF) EMDR intervention in treating post-traumatic and stress-related symptoms of patients with SUD. Methods: Forty patients with different SUD were enrolled in the study. Twenty patients underwent treatment as usual (TAU), the other 20 patients were treated with TAU plus 24 weekly sessions of EMDR. All patients were assessed before and after intervention for several psychological dimensions using specific tools (i.e., BDI-II, DES, IES-R, STAI, and SCL-90-GSI). A repeated measure MANOVA was performed to evaluate both between groups (TAU + EMDR vs. TAU) and within group (pre- vs. post-intervention) effects and interactions. A secondary outcome was the dichotomous variable yielded by the urine drug testing immunoassay (yes/no). Results: The RM-MANOVA revealed both a significant pre-post main effect (p < 0.001), and a significant group-by-time main effect (p < 0.001). Significant improvements on IES-R, DES, and SCL-90-GSI scales were shown in both groups according to time effects (p < 0.05). However, significant greater effects were found for TAU + EMDR group than TAU group. No differences were found between TAU and TAU + EMDR groups in terms of urine drug immunoassay results before and after the interventions. Conclusions: The TAU + EMDR group showed a significant improvement of post-traumatic and dissociative symptoms, accompanied by a reduction in anxiety and overall psychopathology levels, whereas TAU group showed a significant reduction only in post-traumatic symptoms. Although our results can only be considered preliminary, this study suggests that a combined TF- and AF- EMDR protocol is an effective and well-accepted add-on treatment for patients with SUD.

Treating Post-traumatic Stress Disorder in Patients with Multiple Sclerosis: A Randomized Controlled Trial Comparing the Efficacy of Eye Movement Desensitization and Reprocessing and Relaxation Therapy.

OBJECTIVE: Multiple Sclerosis (MS) is a demyelinating autoimmune disease that imposes a significant emotional burden with heavy psychosocial consequences. Several studies have investigated the association between MS and mental disorders such as depression and anxiety, and recently researchers have focused also on Post-traumatic Stress Disorder (PTSD). This is the first study that investigates the usefulness of proposing a treatment for PTSD to patients with MS. METHODS: A randomized controlled trial with patients with MS diagnosed with PTSD comparing Eye Movement Desensitization and Reprocessing (EMDR; n = 20) and Relaxation Therapy (RT; n = 22). The primary outcome measure was the proportion of participants that no longer meet PTSD diagnosis as measured with Clinician Administered PTSD Scale 6-months after the treatment. RESULTS: The majority of patients were able to overcome their PTSD diagnosis after only 10 therapy sessions. EMDR treatment appears to be more effective than RT in reducing the proportion of patients with MS suffering from PTSD. Both treatments are effective in reducing PTSD severity, anxiety and depression symptoms, and to improve Quality of Life. CONCLUSION: Although our results can only be considered preliminary, this study suggests that it is essential that PTSD symptoms are detected and that brief and cost-effective interventions to reduce PTSD and associated psychological symptoms are offered to patients, in order to help them to reduce the psychological burden associated with their neurological condition. TRIAL REGISTRATION: NCT01743664, https://clinicaltrials.gov/ct2/show/NCT01743664.

The efficacy of a Mindfulness Based Intervention for depressive symptoms in patients with Multiple Sclerosis and their caregivers: study protocol for a randomized controlled clinical trial.

BACKGROUND: Multiple Sclerosis has a great impact on psychological functioning of patients and can be associated with various mental health disorders and symptoms. The most prevalent one is depression, which ranges from 15 to 47%. Mindfulness Based Interventions are a relatively brief and cost-effective program that has been studied in patients with several chronic diseases and recently also in patients with Multiple Sclerosis. Mindfulness Based Interventions are based on the assumption that a non-judgmental awareness and acceptance of one's moment-to-moment experience can have a positive effect on the adaptation to the disease, reducing the psychological burden and improving patients' quality of life. Several studies concluded that Mindfulness Based Interventions can be beneficial in terms of improving both psychological and psychical aspects of Multiple Sclerosis, but none of them compared the intervention with an active control group. The primary objective of the study is to evaluate the efficacy of a group-based Mindfulness Based Intervention on depressive symptoms in patients with Multiple Sclerosis, as compared with an active control group. METHODS: The study design is a randomized controlled clinical trial. Eighty-eight patients with Multiple Sclerosis and depressive symptoms will be recruited and randomized to either Mindfulness Based Intervention or an active control group. The latter is designed to control for non-specific elements of the intervention and it comprises psycho-education and relaxation techniques. The primary outcome is the reduction of depressive symptoms as measured via the Beck Depressive Inventory-II. Secondary outcome measures are level of quality of life, anxiety, perceived stress, illness perception, fatigue and quality of interpersonal relationship. Outcomes will be assessed at baseline, after treatment and 6 months after the end of the treatment. Caregivers will participate in groups together with patients. DISCUSSION: As far as we know this trial will be the first randomized controlled trial testing the efficacy of group-based Mindfulness Based Intervention for patients with Multiple Sclerosis with a comparison with an active control group with a specific focus on depressive symptoms. TRIAL REGISTRATION: NCT02611401.

Autologous conditioned serum for the treatment of osteoarthritis and other possible applications in musculoskeletal disorders.

INTRODUCTION: The therapeutic use of interleukin 1 (IL-1) cytokine receptor antagonists (IL-1RA) has promoted the development of new biological therapies for osteoarthritis (OA). Autologous conditioned serum (ACS) is an alternative, safe and well-tolerated treatment in OA. Sources of data We performed a comprehensive search of PubMed, Medline, Cochrane, CINAHL, Embase, SportDiscus, Pedro and Google scholar databases using keywords such as 'interleukin 1', 'osteoarthritis' and 'autologous conditioned serum'. AREAS OF AGREEMENT: ACS, containing endogenous anti-inflammatory cytokines including IL-1RA and several growth factors, could reduce pain and increase function and mobility in mild to moderate knee OA. AREA OF CONTROVERSY: Given the limited data available on the composition of ACS, the mechanisms through which ACS produces clinical improvement, the duration of its effect and the changes in cytokine levels after repeated injections are still unknown. Growing points Although previous clinical data are encouraging and confirm the safety of this modality, given the limitations of current studies, there should be additional, controlled trials to further confirm efficacy for the use of ACS in OA treatment. AREA TIMELY FOR DEVELOPING RESEARCH: ACS can lead to enhancement of tissue regeneration and to reduction of degenerative mechanisms.