Healing grief - an online self-help intervention programme for bereaved Chinese with prolonged grief: study protocol for a randomised controlled trial.

Background: In China, mental health services do not currently meet the needs of bereaved people with symptoms of prolonged grief disorder (PGD). Internet-based grief interventions may help fill this gap, but such programmes have not yet been developed or evaluated in China. The proposed study aims to investigate the effectiveness, acceptability, and feasibility of an online self-help intervention programme named Healing Grief for bereaved Chinese with prolonged grief, and to explore the psychological mechanisms of potential improvements.Methods: We designed a two-arm randomised controlled trial. At least 128 participants will be randomly assigned to either an Internet-based intervention group or a waitlist-control group. The Internet-based intervention will be developed based on the dual process model, integrating techniques of psychoeducation, behavioural activation, cognitive reappraisal, and meaning reconstruction, and will be delivered via expressive writing. The intervention comprises six modules, with two sessions in each module, and requires participants to complete two sessions per week and complete the intervention in 6 weeks. The primary outcomes include effectiveness, acceptability, and feasibility. The effectiveness will be assessed by measures of prolonged grief, posttraumatic stress, anxiety, and depressive symptoms. Acceptability and feasibility will be evaluated using survey and interview on user experience characteristics. Secondary outcomes include moderators and mediators, such as dual process coping, grief rumination, mindfulness, and continuing bond, to explore the psychological mechanisms of potential improvement. Assessments will take place at pre-intervention, post-intervention, and 3-month follow-up.Conclusion: The proposed study will determine the effectiveness, acceptability, and feasibility of the newly developed online self-help intervention for bereaved Chinese with prolonged grief and clarify how the intervention helps with symptom improvements. Such an intervention may play an important role in easing the imbalance between the delivery and receipt of bereavement psychological services in China.

In China, mental health services are not widely available for bereaved people.The proposed study will be the first one to develop and evaluate an Internet-based self-help grief intervention for bereaved Chinese with prolonged grief.The proposed study will determine whether and how the intervention helps to improve the mental health of bereaved Chinese with prolonged grief.

Effectiveness of a specific follow up program for the management of the mental components of post-intensive care syndrome and chronic pain after COVID-19: results from the PAIN-COVID randomized clinical trial.

BACKGROUND: Critical COVID-19 survivors are at risk of developing Post-intensive Care Syndrome (PICS) and Chronic ICU-Related Pain (CIRP). We determined whether a specific care program improves the quality of life (QoL) of patients at risk of developing PICS and CIRP after COVID-19. METHODS: The PAIN-COVID trial was a parallel-group, single-centre, single-blinded, randomized controlled trial. The intervention consisted of a follow up program, patient education on PICS and pain, and a psychological intervention based on Rehm's self-control model in patients with abnormal depression scores (≥8) in the Hospital Anxiety and Depression Scale (HADS) at the baseline visit. QoL was evaluated with the 5-level EQ 5D (EQ 5D 5 L), mood disorders with the HADS, post-traumatic stress disorder (PTSD) with the PCL-5 checklist, and pain with the Brief Pain Inventory short form, the Douleur Neuropathique 4 questionnaire, and the Pain Catastrophizing Scale. The primary outcome was to determine if the program was superior to standard-of-care on the EQ visual analogue scale (VAS) at 6 months after the baseline visit. The secondary outcomes were EQ VAS at 3 months, and EQ index, CIRP incidence and characteristics, and anxiety, depression, and PTSD at 3 and 6 months after baseline visits. CONCLUSIONS: This program was not superior to standard care in improving QoL in critical COVID-19 survivors as measured by the EQ VAS. However, our data can help establish better strategies for the study and management of PICS and CIRP in this population. TRIAL REGISTRATION: # NCT04394169, registered on 5/19/2020.

Feasibility and acceptability of a culturally adapted psychological first aid training intervention (Preparing Me) to support the mental health and well-being of front-line healthcare workers in China: a feasibility randomized controlled trial.

Background: Psychological first aid (PFA) training helps to prepare healthcare workers (HCWs) to manage trauma and stress during healthcare emergencies, yet evidence regarding its effectiveness and implementation is lacking.Method: A two-arm feasibility randomized controlled trial design was conducted in a Chinese tertiary hospital. Participants were randomly allocated to receive either a culturally adapted PFA training (the intervention arm) or psychoeducation (the control arm). Feasibility indicators and selected outcomes were collected.Results: In total, 215 workers who expressed an interest in participating in the trial were screened for eligibility, resulting in 96 eligible participants being randomly allocated to the intervention arm (n = 48) and control arm (n = 48). There was a higher retention rate for the face-to-face PFA training session than for the four online group PFA sessions. Participants rated the PFA training as very helpful (86%), with a satisfaction rate of 74.25%, and 47% reported being able to apply their PFA skills in responding to public health emergencies or providing front-line clinical care. Positive outcome changes were observed in PFA knowledge, skills, attitudes, resilience, self-efficacy, compassion satisfaction, and post-traumatic growth. Their scores on depression, anxiety, stress, and burnout measures all declined. Most of these changes were sustained over 3 months (p < .05). Repeated measures analysis of variance found statistically significant interaction effects on depression (F2,232 = 2.874, p = .046, ηp2 = .031) and burnout (F2,211 = 3.729, p = .018, ηp2 = .037), indicating a greater reduction in symptoms of depression and burnout with PFA compared to psychoeducation training.Conclusion: This culturally adapted PFA training intervention was highly acceptable among Chinese HCWs and was feasible in a front-line care setting. Preliminary findings indicated positive changes for the PFA training intervention on knowledge, skills, attitudes, resilience, self-efficacy, compassion satisfaction, and post-traumatic growth, especially a reduction of depression and burnout. Further modifications are recommended and a fully powered evaluation of PFA training is warranted.

Psychological first aid (PFA) training was culturally adapted and evaluated to help prepare healthcare workers to manage trauma and stress during healthcare emergencies.This culturally adapted PFA training was highly acceptable among Chinese healthcare workers and was feasible in a front-line care setting.Preliminary findings show positive changes for the PFA training intervention on knowledge, skills, attitudes, resilience, self-efficacy, compassion satisfaction, and post-traumatic growth, especially a reduction of depression and burnout.

Efectividad de la Rehabilitación basada en Ejercicio Físico sobre la Sintomatología Prolongada de COVID-19 en Personas Mayores: Una Revisión Sistemática / Effectiveness of Rehabilitation based on Physical Exercise on Prolonged Symptoms of COVID-19 in Older People: A Systematic Review

Propósito. Sistematizar la evidencia respecto a la efectividad de los programas de rehabilitación, basados en la prescripción del ejercicio físico, aplicados en personas mayores con síntomas prolongados de COVID-19. Métodos. Se revisaron las bases de datos PubMed, Science Direct, SPORTDiscus, MEDLINE Complete y Web of Science. Se buscaron estudios de tipo ensayo controlado aleatorizado con fecha de publicación desde el año 2020 hasta octubre de 2022 centrados en programas de rehabilitación, o intervención terapéutica, basados en ejercicio físico en individuos mayores o igual de 60 años que manifiesten síntomas persistentes de COVID-19 posterior a la fase aguda. Resultados. Dos ensayos controlados aleatorizados, que midieron la eficacia de la rehabilitación con ejercicio físico en personas de edad avanzada (mayores o iguales a 60 años), fueron identificados. Los resultados mostraron mejoría de la tolerancia al esfuerzo, la función respiratoria y el bienestar psicológico en los adultos mayores con síntomas post-COVID-19. Sin embargo, la cantidad de estudios es baja y la representación de este grupo etario, también. Conclusión. Los programas de rehabilitación, en personas mayores, basados en ejercicio, son efectivos para tratar los síntomas post-COVID-19. Se necesitan más estudios comparativos de alta calidad, en personas mayores, para desarrollar programas de rehabilitación que permitan afrontar la fase prolongada de la enfermedad.

Purpose. To systematize the evidence regarding the effectiveness of rehabilitation programs, based on the prescription of physical exercise, applied in older people with persistent symptoms of COVID-19. Methods. The PubMed, Science Direct, SPORTDiscus, MEDLINE Complete and Web of Science databases were reviewed. Randomized controlled trial-type studies with a publication date from 2020 to October 2022 and that were focused on physical exercise-based rehabilitation programs that were applied to individuals over or equal to 60 years of age who manifest persistent COVID-19 symptoms post-acute phase. Results. Two randomized controlled trials, which measured the effectiveness of physical exercise-based rehabilitation in elderly people (over or equal to 60 years), were identified. The results showed improvement in exercise tolerance, respiratory function, and psychological well-being in older adults with post-COVID-19 symptoms. However, the number of studies is low and the representation of this age group, too. Conclusion. Physical exercise-based rehabilitation programs in older people are effective in treating post-COVID-19 symptoms. More high-quality comparative studies are needed, in older people, to develop rehabilitation programs that allow coping with the prolonged phase of the disease.

Estudio aleatorizado, doble ciego, sobre la eficacia del tratamiento homeopático en niños con amigdalitis recurrente / Randomized, double-blind study on the efficacy of homeopathic treatment in children with recurrent tonsillitis

La eficacia y seguridad del tratamiento homeopático fueron investigadas en niños con amigdalitis recurrente para la que se indicaba cirugía. Métodos: Estudio clínico prospectivo, aleatorizado, doble ciego, que incluyó 40 niños de entre 3 y 7 años de edad; 20 niños fueron tratados con medicación homeopática y otros 20 niños, con placebo. El seguimiento fue de 4 meses por niño. La evaluación de los resultados fue clínica mediante un cuestionario estándar y examen clínico el primer y último día de tratamiento. La amigdalitis recurrente se definió como ocurrencia de 5 a 7 episodios de amigdalitis bacteriana aguda al año. Resultados: Del grupo de 18 niños que completó el tratamiento homeopático, 14 no presentó episodio alguno de amigdalitis bacteriana aguda; del grupo de 15 niños que recibió placebo, 5 pacientes no presentaron amigdalitis. Esta diferencia fue estadísticamente significativa (p = 0,015). Ninguno de los pacientes presentó efectos secundarios. Conclusiones: El tratamiento homeopático fue efectivo en niños con amigdalitis recurrente, en comparación con el placebo; a 14 niños (78%) ya no se les indicó cirugía. El tratamiento homeopático no se asoció con eventos adversos.

The efficacy and safety of homeopathic treatment was investigated on children with recurrent tonsillitis justifying surgery. Methods: Prospective, randomized,double-blind clinical trial that included 40 children between ages of 3 to 7 years old;20 children were treated with homeopathic medication and 20 children with placebo. Follow up was 4 months per child. Assessment of results was clinical by means of a standard questionnaire and clinical examination on the first and last day of treatment.Recurrent tonsillitis was defined as 5 to 7 episodes of bacterial acute tonsillitis per year. Results: From the group of 18 children who completed homeopathic treatment, 14 did not present any episode of acute bacterial tonsillitis; from the group of 15 children whoreceived placebo 5 patients did not present tonsillitis; this difference was statistically significant (p= 0,015). None of the patient exhibited side effects. Conclusions: Homeopathic treatment was effective in children with recurrent tonsillitis compared to placebo, 14 children (78%) were no longer indicated surgery. Homeopathic treatment was not associated with adverse events.

Dispositivos robóticos de mano en neurorrehabilitación: revisión sistemática sobre viabilidad y efectividad en la rehabilitación del ictus / Hand robotic devices in neurorehabilitation: A systematic review on the feasibility and effectiveness of stroke rehabilitation

La terapia asistida por robot es una intervención relativamente nueva, cada vez más empleada en el tratamiento rehabilitador del paciente con ictus. Permite incrementar el número de repeticiones en la realización de movimientos de tareas específicas. Para esta revisión se ha realizado una búsqueda entre agosto y octubre de 2021 en las bases de datos PubMed, Web of Science, Scopus, Cochrane, PEDro y OTseeker, seleccionando un total de seis ensayos controlados y aleatorizados donde se utilizara la terapia de mano asistida por robot en la rehabilitación del ictus. Los estudios coinciden en que la terapia de mano asistida por robot presenta beneficios en todas las fases de la rehabilitación del ictus que se traducen en mejoras motoras y funcionales del miembro superior y en mejoras en la negligencia hemiespacial.(AU)

Robot-assisted therapy is a relatively new intervention, increasingly used in the rehabilitation treatment of stroke patients. It allows to increase the number of repetitions in the performance of specific tasks movements. For this review, a search was carried out between August and October 2021 in the PubMed, Web of Science, Scopus, Cochrane, PEDro and OTseeker databases, selecting a total of six randomized controlled trials where robot-assisted hand therapy was used in stroke rehabilitation. Studies agree that robot-assisted hand therapy has benefits in all phases of stroke rehabilitation that translate into motor and functional improvements of the upper limb and improvements in hemispatial neglect.(AU)

[Hand robotic devices in neurorehabilitation: A systematic review on the feasibility and effectiveness of stroke rehabilitation]. / Dispositivos robóticos de mano en neurorrehabilitación: revisión sistemática sobre viabilidad y efectividad en la rehabilitación del ictus.

Robot-assisted therapy is a relatively new intervention, increasingly used in the rehabilitation treatment of stroke patients. It allows to increase the number of repetitions in the performance of specific tasks movements. For this review, a search was carried out between August and October 2021 in the PubMed, Web of Science, Scopus, Cochrane, PEDro and OTseeker databases, selecting a total of six randomized controlled trials where robot-assisted hand therapy was used in stroke rehabilitation. Studies agree that robot-assisted hand therapy has benefits in all phases of stroke rehabilitation that translate into motor and functional improvements of the upper limb and improvements in hemispatial neglect.

Hot Yoga Leads to Greater Well-being: A Six-week Experience-sampling RCT in Healthy Adults

Practicing hot yoga may bring significant psychological benefits, but it is largely unstudied. We examined the effects of hot yoga on multifaceted well-being indicators with 290 healthy yoga-naïve volunteers partaking in a six-week randomized controlled trial. Participants completed questionnaires pre- and post-intervention, and reported their emotional experiences four times per day throughout an experience-sampling study. Results revealed that the hot yoga group (n = 137) improved their well-being from pre- to post-treatment, comparing to the wait-list control group (n = 153). These improvements included life satisfaction, general health, mindfulness, peace of mind, and eudaimonic well-being (ΔR2 ranging from .01 to .08)—but not flourishing, which describes major aspects of social-psychological functioning. Multilevel analyses demonstrated that momentary positive emotional experiences increased significantly throughout the trial in the yoga group only (conditional R2 = .68), particularly when attending a yoga class (conditional R2 = .50). Interestingly, this increase in momentary positive emotion explained the improvement in post-intervention mindfulness, peace of mind, and general health by 21%, 31%, and 11%, respectively. Finally, the benefits of hot yoga were more notable in individuals with lower levels of baseline eudaimonic well-being (conditional R2 = .45), flourishing (conditional R2 = .61), and mental well-being (conditional R2 = .65), even after ruling out any possible ceiling effects. To sum up, this study demonstrated multiple psychological benefits of hot yoga and its potential to be an effective positive psychology intervention. Future research—especially considering an active control group—is warranted. (AU)

La práctica del hot yoga puede aportar importantes ventajas psicológicas, aunque apenas se ha estudiado. Analizamos los efectos del hot yoga sobre una gran variedad de indicadores de bienestar en una muestra de 290 voluntarios sin experiencia en yoga que tomaron parte en un ensayo controlado aleatorio de seis semanas. Los participantes contestaron cuestionarios antes y después de la intervención, dando cuenta de sus experiencias emocionales cuatro veces al día a lo largo de un estudio de muestreo de experiencias. Los resultados mostraron que el bienestar del grupo de hot yoga (n = 137) aumentó del pretratamiento al postratamiento en comparación con el grupo de control de lista de espera (n = 153), mejorando la satisfacción en la vida, la salud en general, la atención plena, la paz mental y el bienestar eudaimónico (ΔR2 entre .01 y .08), aunque no en prosperidad psicosocial, que describe aspectos importantes del funcionamiento social psicológico. Los análisis multinivel desvelaron que se daba un gran aumento de las experiencias emocionales positivas momentáneas a lo largo de todo el ensayo únicamente en el grupo de yoga (R2 condicional = .68), sobre todo al asistir a clase de yoga (R2 condicional = .50). Es interesante ver que este aumento de la emoción positiva momentánea explicaba la mejora de la atención plena, la paz mental y la salud en general en un 21%, 31% y 11% respectivamente tras la intervención. Por último, los beneficios del hot yoga destacaban más en personas con menor bienestar eudaimónico base (R2 condicional = 45), prosperidad psicosocial (R2 condicional = .61) y bienestar mental (R2 condicional = .65), incluso tras descartar los posibles efectos techo. Resumiendo, este estudio ha demostrado los muchos efectos psicológicos del hot yoga y su potencial como eficaz intervención en psicología positiva. La investigación futura (en especial teniendo en cuenta un grupo de control activo) está justificada. (AU)

The impact of responsible fatherhood programs on parenting, psychological well-being, and financial outcomes: A randomized controlled trial.

The objective of this study was to examine differences in parenting, psychological well-being, and economic outcomes between fathers receiving two different programs offered by Fathers & Families Support Center for economically disadvantaged fathers: (a) Family Formation (FF), a 6-week/240-h program focused on economic stability/mobility, responsible fatherhood, and healthy relationships, with case management and legal services; (b) Economic Stability (ES), a 4-week/80-h program focused only on economic stability with limited case management and legal services. A randomized controlled trial (RCT) was used to compare fathers in FF (n = 350) vs. ES (n = 342). Surveys were administered at enrollment and 3- and 12-months postintervention. Linear and generalized linear mixed models were used to assess changes in program outcomes over time and across study groups. Four hundred and eighty-two fathers responded to either follow-up survey (251 FF, 231 ES). Nearly all (98%) were non-white (93% Black, 5% other/mixed race) and were on average 34 years old. Approximately 46% attended ≥75% of program sessions (FF 48% vs. ES 44%). Both FF and ES groups experienced improvements in parenting, psychological well-being, and financial outcomes after the programs, but changes in outcomes over time did not differ significantly by program. The lack of difference in outcomes between fathers in FF and ES groups could be due to a similar core focus on employment-related curriculum for both groups. Gaining financial stability could have contributed to positive improvements in other fatherhood domains. Implications for future research and practice are discussed herein.

El objetivo de este estudio fue analizar las diferencias en la crianza, el bienestar psicológico y los resultados económicos entre padres que recibían dos programas diferentes ofrecidos por el Centro de Apoyo a los Padres y las Familias (Fathers & Familiares Support Center) para padres desfavorecidos económicamente: (a) Formación de una Familia (Family Formation, FF), un programa de 6 semanas/240 horas centrado en la estabilidad/movilidad económica, la paternidad responsable y las relaciones saludables, con gestión de casos y servicios legales; (b) Estabilidad Económica (Economic Stability, ES), un programa de 4 semanas/80 horas centrado solamente en la estabilidad económica con poca gestión de casos y servicios legales. Se usó un ensayo controlado aleatorizado para comparar a los padres de FF (n=350) con los de ES (n=342). Se realizaron encuestas en la inscripción y a los 3 y a los 12 meses posteriores a la intervención. Se usaron modelos lineales y modelos mixtos lineales generalizados para evaluar los cambios en los resultados de los programas con el tiempo y entre los grupos de estudio. 482 padres respondieron a cada encuesta de seguimiento (251 FF, 231 ES). Casi todos (el 98 %) eran de color (el 93 % negros, el 5 % de otra raza o de raza mestiza) y tenían, en promedio, 34 años. Aproximadamente el 46 % asistió a más del 75 % de las sesiones de los programas (el 48 % de FF frente al 44 % de ES). Tanto el grupo de FF como el de ES tuvieron mejoras en la crianza, en el bienestar psicológico y en los resultados económicos después de los programas, pero los cambios en los resultados con el tiempo no variaron significativamente por programa. La falta de diferencia en los resultados entre los padres del grupo de FF y los del grupo de ES podría deberse a un enfoque principal similar en un currículo relacionado con el empleo para ambos grupos. La adquisición de estabilidad económica podría haber contribuido a mejoras positivas en otras áreas de la paternidad. Se comentan las consecuencias para la futura investigación y la práctica.

Rompiendo el efecto ''techo de cristal'' en la generación de evidencia clínica de alto nivel en ortopedia y traumatología / Breaking the "glass ceiling" effect in the generation of high-level clinical evidence in orthopedics and traumatology

Introduction: In clinical studies involving common orthopedic problems and traumatic injuries, randomization methods are difficult to orchestrate. The lack of high-level clinical evidence based on prospective, randomized, double-blind studies is often cited as a major reason for rejecting proposed therapeutic advances in orthopedic surgery. Materials and methods: This opinion document summarizes the limitations of clinical trials in surgical subspecialties. A consensus is presented about how the practicing orthopedic surgeon can produce high-quality clinical evidence and thus make changes to their clinical practice protocols. Results: This literature review revealed that level of evidence classifications vary among surgical subspecialties. Research in orthopedics and traumatology is primarily directed toward diagnosis, preferred treatment, and economic decision analysis, while other prognostic classifications are preferred in other areas, such as plastic surgery. In orthopedics, double-blind controlled studies are rare and often impractical or even unethical. Crossover between randomized surgical trials of study groups is more common. Other difficulties in surgical trials range from: lack of organizational and financial support, institutional approval or ethics committee and registration requirements for clinical trials, and to insufficient time outside of an already busy clinical program to dedicate to this laborious task. uncompensated task. Conclusion: Orthopedic surgery is a subspecialty based on experience and skill. Many innovations begin with enterprising surgeons reporting opinion reports or retrospective cohort studies, many of which are biased. Prospective observational cohort studies with consistent results may offer higher grade clinical evidence than poorly executed randomized trials.

Riesgo de desarrollar LIE-AG en pacientes con tamizaje inicial positivo para VPH y citología cervicovaginal negativa en seguimiento hasta 10 años: revisión sistemática y metaanálisis / Risk of developing H-SIL in patients with initial positive screening for HPV and negative cervicovaginal cytology in follow-up up to 10 years: systematic review and meta-analysis

Resumen Introducción: El cáncer de cérvix es el segundo en frecuencia y el tercero en mortalidad; la infección por el virus del papiloma humano (VPH) está asociada al riesgo de cáncer; sin embargo, no se conoce el riesgo acumulado a 1, 2, 3, 5 y 10 años. Objetivo: Determinar el riesgo de las pacientes VPH positivo con evaluación inicial citológica negativa para desarrollar lesión intraepitelial de alto grado a lo largo del tiempo. Método: Se realizó una revisión sistemática de artículos en inglés y español de los últimos 20 años, usando las bases de datos PubMed, Cochrane, LILACS, ProQuest y Embase. Se incluyeron ensayos clínicos aleatorizados en los que se determinaba el estado VPH y se realizaba seguimiento con citología cervicovaginal a 1, 2, 3, 5 y 10 años en mujeres de 20-64 años. Resultados: Se incluyeron siete ensayos clínicos aleatorizados, con un total de 98.521 mujeres, de ellas 8820 VPH positivo y 89.701 VPH negativo al ingreso, seguidas hasta por 10 años con citología cervicovaginal, encontrando que la infección por VPH es un factor de riesgo para desarrollar lesiones intraepiteliales de alto grado a 2, 5 y 10 años, con un riesgo relativo de 110.94 (79.41-154.97), 83.65 (55.22-126.73) y 29.71 (5.72-154.33), respectivamente. Conclusiones: La infección por VPH es un factor de riesgo importante para el desarrollo de lesiones intraepiteliales de alto grado a 2, 5 y 10 años.

Abstract Introduction: Cervical cancer is the second in frequency and the third in mortality, infection by the human papillomavirus (HPV) is associated with the risk of increased cancer; however, the cumulative risk of 1, 2, 3, 5 and 10 years is not known. Objective: To determine the risk of HPV-positive patients with negative initial cytological evaluation for developing high-grade intraepithelial lesion over time. Method: A systematic review of articles in English and Spanish in the last 20 years was carried out, using the PubMed, Cochrane, LILACS, ProQuest and Embase databases. Randomized clinical trials were included in which HPV was performed and subsequent follow-up with cervicovaginal cytology at 1, 2, 3, 5 and 10 years in women aged 20-64 years. Results: Seven randomized clinical trials were included, a total of 98,521 women, 8820 with positive HPV and 89701 negative on admission and followed up for up to 10 years with cervicovaginal cytology. Finding that HPV infection is a risk factor for developing high-grade intraepithelial lesion at 2, 5 and 10 years with a relative risk of 110.94 (79.41-154.97), 83.65 (55.22- 126.73) and 29.71 (5.72-154.33), respectively. Conclusions: HPV infection is an important risk factor for the development of high-grade intraepithelial lesion at 2, 5 and 10 years.

Análisis del efecto a largo plazo de un programa de estimulación cognitiva en mayores con deterioro cognitivo leve en Atención Primaria: ensayo controlado aleatorizado / Long-term effect analysis of a cognitive stimulation program in mild cognitive impairment elderly in Primary Care: A randomized controlled trial

Objetivo: Aportar evidencias de la eficacia de una intervención comunitaria en salud a través de un programa de estimulación cognitiva (PEC) implementada con el paso del tiempo en mayores con deterioro cognitivo leve en la comunidad. Diseño: Seguimiento de un ensayo controlado aleatorizado (normas grupo CONSORT). Emplazamiento: Centro de salud San José Norte-Centro y Fundación La Caridad (Zaragoza). Participantes: Veintinueve personas ≥65 años, con 24-27 puntos en el MEC-35 que completaron el ensayo a los 48 meses, 15 aleatorizados en el grupo intervención y 14 en el grupo control. Intervenciones: Se realizaron 10 sesiones, 45min/semana, durante 10 semanas, con el cuaderno rojo de activación mental que ejercita: memoria, orientación, lenguaje, praxis, gnosis, cálculo, percepción, razonamiento lógico, atención y funciones ejecutivas. Mediciones principales: MEC-35, Set-test, Barthel, Lawton-Brody, subescala de ansiedad Goldberg y Yesavage abreviado (GDS-15). Resultados: Analizando los incrementos sobre el nivel basal para MEC-35, el grupo intervención obtiene, de media: postintervención 3,14 puntos, a los 6 meses 3,76 puntos y a los 12 meses 2,26 puntos más que el grupo control, siendo estos incrementos estadísticamente significativos. A los 48 meses el grupo intervención sigue obteniendo 2 puntos más que el control, sin ser significativos. La intervención no mejoró el desempeño en fluidez verbal, actividades de la vida diaria ni estado de ánimo. Conclusiones:Nuestro PEC podría ser eficaz en la mejora de la cognición general, medida con el MEC-35, en postintervención, a los 6, 12 y 48 meses. No se evidencian mejoras en fluidez verbal, actividades de la vida diaria ni estado de ánimo.(AU)

Objective: To provide evidence about the efficacy of a community health intervention through a cognitive stimulation program at long term in older people with mild cognitive impairment. Design: Randomized controlled trial (CONSORT group norms). Location: San José Norte-Centro Primary Care Center and La Caridad Foundation (Zaragoza, Spain). Participants: Twenty-nine people over 65 years old with a 24-27 MEC score that completed 48 months follow up. They were randomized between the intervention group (15) and the control group (14). Interventions: The intervention was applied in 10 sessions of 45min for 10 weeks using the red notebook tool for mental activation that works memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention and executive functions. Main measurements: The main outcome variables were MEC-35, Set-test, Barthel index, Lawton-Brody scale, Goldberg anxiety scale and Yesavage geriatric depression scale short form. Results: Increases of the main result variable over the baseline level of MEC-35 were analyzed. On average, the intervention group obtained higher scores than control: 3.14 points post intervention, 3.76 points after 6 months and 2.26 points more than control group after 12 months. All the differences were statistically significant. After 48 months the intervention group obtained 2 points more than control group. The intervention did not improve verbal fluency, activity daily living and mood. Conclusions: Our cognitive stimulation program seems to improve cognitive performance, measured with the variable MEC-35 at post intervention, 6, 12 and 48 months. There is no evidence of improvement in verbal fluency, activity daily livings and mood.(AU)

Music therapy was noninferior to verbal standard treatment of traumatized refugees in mental health care: Results from a randomized clinical trial.

Background: Many people with refugee backgrounds suffer from trauma-related complex social and psychological problems, and compliance with standard psychological treatment tends to be low. More culturally adaptable treatment options seem to be needed. Objective: We aimed to investigate whether the music therapy method: 'trauma-focused music and imagery' (tr-MI), characterized by a particular focus on arousal and affect regulation, would be equally effective as the standard psychological talk therapies for ameliorating trauma symptoms in Danish refugees. Methods: A pragmatic, noninferiority, parallel, randomized controlled trial with six-month follow-up was carried out at three clinics for refugees in the public mental health services of the Psychiatry (DK). Seventy-four adults diagnosed with posttraumatic stress disorder (PTSD) were allocated to either music therapy sessions (tr-MI, N = 39) or psychological treatment as usual (TAU, N = 35). Western classical music, new age music, and music from the participants' own national culture were used to generate inner imagery, following a phased treatment protocol. Homework entailed listening to music. The primary outcome was the measurement of trauma symptoms by the Harvard Trauma Questionnaire, section IV (HTQ-IV); secondary measures were somatoform and psychoform dissociation (DSS-20), SDQ-20), attachment (RAAS), and well-being (WHO-5). Treatment effects reflected by primary and secondary measures were estimated using linear mixed models. Results: Tr-MI was noninferior to TAU (mean difference at follow-up HTQ-IV: 0.14, CI (-0.10; 0.38), with a - 0.3 noninferiority margin). A high dropout rate of 40% occurred in the TAU group, compared to 5% in the music therapy group. Secondary measures generated small to medium effect sizes in both groups, with significant medium effect sizes for well-being and psychoform dissociation at follow-up in tr-MI. Conclusions: Tr-MI is an innovative form of psychological treatment in refugee mental health services. Trials comparing music therapy to standardized therapy are needed to substantiate the evidence base for tr-MI therapy.

Antecedentes: Muchas personas con antecedente de condición de refugiadas sufren complejos problemas psicológicos y sociales relacionados con el trauma, y el cumplimiento con el tratamiento psicológico estándar tiende a ser bajo. Parecen ser necesarias opciones de tratamiento más culturalmente adaptadas.Objetivo: Apuntamos a investigar si el método de músico-terapia: 'música e imaginería focalizada en el trauma' (tr-MI), caracterizado por un enfoque particular en el nivel de alerta y regulación emocional, podría ser igualmente efectivo como las terapias psicológicas de conversación para aliviar síntomas de trauma en refugiados daneses.Métodos: Se llevó a cabo un ensayo clínico aleatorizado controlado, pragmático, de no inferioridad, paralelo, con seis meses de seguimiento en tres clínicas para refugiados en servicios públicos de salud mental de Psiquiatría en Dinamarca. Setenta y cuatro adultos diagnosticados con Trastorno de estrés postraumático (TEPT) fueron asignados a sesiones de músico-terapia (tr-MI, N = 39) o al tratamiento psicológico de costumbre (TAU, N = 35). Se utilizó música clásica occidental, música new age, y música de la propia cultura nacional de los participantes, para generar imaginería interior, siguiendo un protocolo de tratamiento por fases. La tarea implicaba escuchar música. El resultado principal fue la medición de síntomas de trauma a través del Cuestionario de Trauma de Harvard, sección IV (HTQ-IV); las mediciones secundarias fueron disociación somatomorfa y psicomorfa (DSS-20, SDQ-20), apego (RAAS), y bienestar (WHO-5). Los efectos del tratamiento reflejados por mediciones primarias y secundarias fueron estimados usando modelos lineales mixtos.Resultados: Tr-MI no fue inferior a TAU (diferencia promedio al seguimiento HTQ-IV: 0.14, IC −0.10; 0.38), con un margen de no-inferioridad de −0.3). Una alta tasa de deserción de un 40% ocurrió en el grupo TAU, comparado con un 5% en el grupo de músico-terapia. Las mediciones secundarias generaron tamaños de efecto pequeños a medianos en ambos grupos, con un tamaño del efecto mediano significativo para bienestar y disociación psicomorfa al seguimiento en tr-MI.Conclusiones: Tr-MI es una forma innovadora de tratamiento psicológico en servicios de salud mental para refugiados. Se necesitan ensayos comparando músico-terapia con terapia estandarizada para probar la base de evidencia para la terapia tr-MI.

[Long-term effect analysis of a cognitive stimulation program in mild cognitive impairment elderly in Primary Care: A randomized controlled trial]. / Análisis del efecto a largo plazo de un programa de estimulación cognitiva en mayores con deterioro cognitivo leve en Atención Primaria: ensayo controlado aleatorizado.

OBJECTIVE: To provide evidence about the efficacy of a community health intervention through a cognitive stimulation program at long term in older people with mild cognitive impairment. DESIGN: Randomized controlled trial (CONSORT group norms). LOCATION: San José Norte-Centro Primary Care Center and La Caridad Foundation (Zaragoza, Spain). PARTICIPANTS: Twenty-nine people over 65 years old with a 24-27 MEC score that completed 48 months follow up. They were randomized between the intervention group (15) and the control group (14). INTERVENTIONS: The intervention was applied in 10 sessions of 45min for 10 weeks using the red notebook tool for mental activation that works memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention and executive functions. MAIN MEASUREMENTS: The main outcome variables were MEC-35, Set-test, Barthel index, Lawton-Brody scale, Goldberg anxiety scale and Yesavage geriatric depression scale short form. RESULTS: Increases of the main result variable over the baseline level of MEC-35 were analyzed. On average, the intervention group obtained higher scores than control: 3.14 points post intervention, 3.76 points after 6 months and 2.26 points more than control group after 12 months. All the differences were statistically significant. After 48 months the intervention group obtained 2 points more than control group. The intervention did not improve verbal fluency, activity daily living and mood. CONCLUSIONS: Our cognitive stimulation program seems to improve cognitive performance, measured with the variable MEC-35 at post intervention, 6, 12 and 48 months. There is no evidence of improvement in verbal fluency, activity daily livings and mood. Clinicaltrials.gov Identifier: NCT03831061.

Can we increase the subjective well-being of the general population? An umbrella review of the evidence

Introduction: Subjective well-being (SWB) refers to being satisfied with one's life, having positive affect and having little negative affect. We may understand it as a subjective definition of good life, or in colloquial terms “happiness”, and it has been associated with several important benefits such as lower mortality. In the last decades, several randomized controlled trials (RCT) have investigated the efficacy of several interventions in increasing SWB in the general population but results from different disciplines have not been integrated.MethodsWe conducted an umbrella review of systematic reviews and meta-analyses of RCT that assess the efficacy of any kind of interventions in increasing SWB in the general population, including both positive psychology interventions (PPI) and other interventions. We (re)calculated the meta-analytic statistics needed to objectively assess the quality of the evidence of the efficacy of each type of intervention in improving each component of SWB according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.ResultsThere was moderate-quality evidence that PPI might induce small decreases of negative affect, and low-quality evidence that they might induce moderate increases of positive affect. We found similar results for those PPI specifically consisting in conducting acts of kindness (especially spending money on or giving items to others), for which there was low-quality evidence that they might induces small increases of life satisfaction, but not for PPI specifically consisting in practicing gratitude. Quality of the evidence of the efficacy for the other interventions included in the umbrella review (yoga, resilience training, physical activity, leisure, control enhancement, psychoeducation, and miscellaneous) was very low. (AU)

Introducción: El bienestar subjetivo (BS) se refiere a estar satisfecho con la vida, tener afecto positivo y tener poco afecto negativo. Podemos entenderlo como una definición subjetiva de la buena vida, o en términos coloquiales, como «felicidad», y se ha asociado con varios beneficios importantes, como una menor mortalidad. En las últimas décadas, varios ensayos controlados aleatorizados (ECA) han investigado la eficacia de varias intervenciones para aumentar el BS en la población general, pero los resultados de las diferentes disciplinas no se han integrado.MétodosRealizamos una revisión paraguas de revisiones sistemáticas y metaanálisis de ECA que evaluasen la eficacia de cualquier tipo de intervención para aumentar el BS en la población general, incluidas tanto las intervenciones de psicología positiva (IPP) como otras intervenciones. (Re)calculamos los estadísticos metaanalíticos necesarios para evaluar objetivamente la calidad de la evidencia de la eficacia de cada tipo de intervención para mejorar cada componente del BS de acuerdo con el Grading of Recommendations Assessment, Development and Evaluation (GRADE).ResultadosHubo evidencia de moderada calidad de que las IPP podrían inducir pequeñas disminuciones de afecto negativo, así como evidencia de baja calidad de que podrían inducir aumentos moderados de afecto positivo. Encontramos resultados similares para aquellas IPP que consistían específicamente en realizar actos de bondad (especialmente gastar dinero en o dar artículos a otros), para las cuales había evidencia de baja calidad de que podrían inducir pequeños aumentos de satisfacción con la vida, pero no para las IPP que consistían específicamente en practicar la gratitud. La calidad de la evidencia de la eficacia para las otras intervenciones incluidas en la revisión paraguas (yoga, entrenamiento de resiliencia, actividad física, ocio, mejora del control, psicoeducación y miscelánea) fue muy baja. (AU)

Effectiveness of Functional Family Therapy in a Non-Western Context: Findings from a Randomized-Controlled Evaluation of Youth Offenders in Singapore.

This study is the first to evaluate Functional Family Therapy (FFT) in a non-Western culture. The effectiveness of FFT was examined in relation to three proximal outcomes relevant to youth offender rehabilitation: (i) mental well-being, (ii) family functioning, and (iii) probation completion. 120 youth probationers (Mage = 16.2, SD = 1.33) were randomly assigned to receive either standard probation services-Treatment-As-Usual (TAU; n = 57)-or FFT in addition to TAU (FFT; n = 63). Data on psychometric measures of mental well-being and family functioning were obtained at (i) preprogram, (ii) postprogram, and (iii) at the end of probation. Probation completion data were obtained from casefile records. Mean mental well-being scores of the FFT group improved from pre- to post-treatment, and gains were maintained at follow-up. However, there was a nonsignificant trend for the FFT group showing higher rates of reliable change and clinical recovery on the mental well-being scale. There were no group differences in family functioning scores over time. However, there was a significant trend for the FFT group showing higher rates of reliable change and clinical recovery on the family functioning scale. Probation completion rates were 88.9% and 70.2% for the FFT and TAU groups, respectively. Youth in the FFT group were significantly more likely to complete probation successfully. The results support FFT's effectiveness in Singaporean youth offenders. At a broader level, the study findings support the cross-cultural effectiveness of FFT in, and transportability to, a non-Western culture.

Este estudio es el primero en evaluar la Terapia Familiar Funcional (TFF) en una cultura no occidental. Se analizó la eficacia de la TFF en relación con tres resultados proximales relevantes para la rehabilitación de los delincuentes juveniles: (i) bienestar mental, (ii) funcionamiento familiar y (iii) término de la libertad condicional. Se distribuyeron aleatoriamente 120 jóvenes en libertad condicional (Edad Promedio = 16.2, Desviación Típica= 1.33) para recibir servicios de libertad condicional estándar-tratamiento habitual (TH; n = 57)-o TFF además del TH (TFF; n = 63). Se obtuvieron datos sobre las medidas psicométricas de bienestar mental y funcionamiento familiar en los siguientes momentos (i) antes del programa, (ii) después del programa y (iii) al final de la libertad condicional. Se obtuvieron datos del término de la libertad condicional de los expedientes judiciales. Los puntajes del bienestar mental promedio del grupo de TFF mejoraron desde antes a después del tratamiento, y se mantuvieron los avances en el seguimiento. Sin embargo, hubo una tendencia no significativa en el grupo de TFF que indicó índices más altos de cambio fiable y recuperación clínica en la escala de bienestar mental. No hubo diferencias entre los grupos en los puntajes de funcionamiento familiar en el transcurso del tiempo. Sin embargo, hubo una tendencia significativa en el grupo de TFF que indicó índices más altos de cambio fiable y recuperación clínica en la escala de funcionamiento familiar. Los índices de término de la libertad condicional fueron 88.9 % y 70.2 % en los grupos de TFF y de TH respectivamente. Los jóvenes del grupo de TFF fueron considerablemente más propensos a terminar la libertad condicional satisfactoriamente. Los resultados respaldan la eficacia de la TFF entre los delincuentes juveniles singapurenses. A nivel general, los resultados del estudio respaldan la eficacia intercultural de la TFF en una cultura no occidental y la transportabilidad hacia ella.

Pelvic floor muscle training in the treatment of pelvic organ prolapse: A meta-analysis of randomized controlled trials. / Entrenamiento muscular del suelo pélvico en el tratamiento del prolapso de órganos pélvicos: un metaanálisis de ensayos controlados aleatorizados.

BACKGROUND: We aimed to assess the overall effect of pelvic muscle training (PFMT) on patients with pelvic organ prolapse (POP) based on eligible randomized controlled trials (RCT). METHODS: We searched the following databases, such as PubMed, Cochrane, and Embase, to identify eligible RCT based on the index words updated to December 2018. We also searched the publications related to the present study. Odds rations (OR), and mean difference (MD) along with 95% confidence interval (95% CI) were used to analyze the main outcomes. RESULTS: In this meta-analysis, 15 RCTs were included with a total of 1309 patients in the PFMT group and a total of 1275 patients in the control group. The overall results showed no significant difference in the incidence of add 2 POP-Q stages (RR: 0.55, 95%CI: 0.19-1.63), add 1 POP-Q stages (RR: 1.04, 95%CI: 0.69-1.57), no POP-Q stages change (RR: 0.94, 95%CI: 0.81-1.09), reduce 2 POP-Q stages (RR: 1.72, 95%CI: 0.79-3.76), self-reported same symptom change (RR: 0.70, 95%CI: 0.45-1.09), and self-reported worse symptom change (RR: 0.67, 95%CI: 0.22-2.03) between the 2groups. Besides, the incidence of reduce 1 POP-Q stages was significantly higher in the PFMT group than that of the control group (RR: 1.80, 95%CI: 1.20-2.69), and the PFMT significantly changed the self-reported symptoms with better outcomes when compared with the control group (RR: 2.90, 95%CI: 1.72-4.89). However, after the therapy, the PFMT group decreased the POP-SS (SMD: -0.24, 95%CI: -0.71-0.22), POPDI-6 (SMD: -0.14, 95%CI: -0.43-0.15), CRADI-8 (SMD: -0.03, 95%CI: -0.16-0.11), and UDI-6 (SMD: -0.17, 95%CI: -0.43-0.10) versus the control group, but without statistical significance. CONCLUSION: PMFT showed better effect in reducing 1 POP-Q stages, changing the self-reported symptoms with better outcomes, decreasing the score of POP-SS, POPDI-6, CRADI-8, and UDI-6 in women with POP versus the control group. However, more high-quality multicenter RCTs with a larger sample size are needed to confirm the present conclusions.

Can we increase the subjective well-being of the general population? An umbrella review of the evidence.

INTRODUCTION: Subjective well-being (SWB) refers to being satisfied with one's life, having positive affect and having little negative affect. We may understand it as a subjective definition of good life, or in colloquial terms "happiness", and it has been associated with several important benefits such as lower mortality. In the last decades, several randomized controlled trials (RCT) have investigated the efficacy of several interventions in increasing SWB in the general population but results from different disciplines have not been integrated. METHODS: We conducted an umbrella review of systematic reviews and meta-analyses of RCT that assess the efficacy of any kind of interventions in increasing SWB in the general population, including both positive psychology interventions (PPI) and other interventions. We (re)calculated the meta-analytic statistics needed to objectively assess the quality of the evidence of the efficacy of each type of intervention in improving each component of SWB according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: There was moderate-quality evidence that PPI might induce small decreases of negative affect, and low-quality evidence that they might induce moderate increases of positive affect. We found similar results for those PPI specifically consisting in conducting acts of kindness (especially spending money on or giving items to others), for which there was low-quality evidence that they might induces small increases of life satisfaction, but not for PPI specifically consisting in practicing gratitude. Quality of the evidence of the efficacy for the other interventions included in the umbrella review (yoga, resilience training, physical activity, leisure, control enhancement, psychoeducation, and miscellaneous) was very low. CONCLUSION: There is some evidence that PPI, and specially conducting acts of kindness such as spending money on others, may increase the SWB of the general population. The quality of the evidence of the efficacy for other interventions (e.g., yoga, physical activity, or leisure) is still very low. Registration number: PROSPERO CRD42020111681.

Comparing Cognitive Behavioral Therapy and Systemic Therapy for Social Anxiety Disorder: Randomized Controlled Pilot Trial (SOPHO-CBT/ST).

This randomized controlled trial (RCT) aimed to pilot the newly developed manualized and monitored systemic therapy (ST) for social anxiety disorder (SAD), as compared to manualized and monitored cognitive behavioral therapy (CBT). We conducted a prospective multicenter, assessor-blind pilot RCT on 38 outpatients (ICD F40.1; Structured Clinical Interview for DSM (SCID); Liebowitz Social Anxiety Scale, LSAS-SR >30). The primary outcome was level of social anxiety (LSAS-SR) at the end of treatment. A total of 252 persons were screened, and 38 patients were randomized and started therapy (CBT: 20 patients; ST: 18 patients; age: M = 36 years, SD = 14). Within-group, simple-effect intent-to-treat analyses (ITT) showed significant reduction in LSAS-SR (CBT:d = 1.04; ST:d = 1.67), while ITT mixed-design ANOVA demonstrated the advantage of ST (d = 0.81). Per-protocol analyses supported these results. Remission based on reliable change indices also demonstrated significant difference (LSAS-SR: 15% in CBT; 39% in ST;h: 0.550), supported by blind diagnosticians' ratings of those who completed therapy (SCID; 45% in CBT, 78% in ST,p = .083). No adverse events were reported. CBT and ST both reduced social anxiety, supporting patient improvement with the newly developed ST for SAD; this has yet to be verified in a subsequent confirmatory RCT.

Este ensayo controlado aleatorizado tuvo como finalidad probar la terapia sistémica (TS) estandarizada y monitoreada recientemente desarrollada para el trastorno de ansiedad social en comparación con la terapia cognitivo-conductual (TCC) estandarizada y monitoreada. Realizamos un ensayo controlado aleatorizado prospectivo, multicentro y con enmascaramiento para el evaluador en 38 pacientes ambulatorios (CIE F40.1; Entrevista Clínica Estructurada para los trastornos del DSM (SCID); Escala de Ansiedad Social de Liebowitz, LSAS-SR > 30). El resultado principal fue el nivel de ansiedad social (LSAS-SR) al final del tratamiento. Se evaluó a un total de 252 personas, 38 pacientes fueron aleatorizados y comenzaron la terapia (TCC: 20 pacientes; TS: 18 pacientes; edad: promedio= 36 años, desviación estándar = 14). Los análisis intragrupales, de efecto simple, con intención de tratar demostraron una reducción significativa del LSAS-SR (TCC: d = 1.04; TS: d = 1.67), mientras que el análisis de varianza de diseño mixto con intención de tratar demostró la ventaja de la TS (d = 0.81). Los análisis por protocolo respaldaron estos resultados. La remisión basada en los índices de cambio fiable también demostró una diferencia significativa (LSAS-SR: 15% en la TCC; 39% en la TS; h: 0.550), respaldada por diferencias casi significativas en las valoraciones con enmascaramiento para los evaluadores de aquellos que completaron la terapia (SCID; 45% en la TCC, 78% en la TS, p = 0.083). No se informaron efectos adversos. Tanto la TCC como la TS reducen la ansiedad social y respaldan la mejora de los pacientes con la terapia sistémica recientemente desarrollada para los trastornos de ansiedad social; esto aun debe verificarse en un ensayo controlado aleatorizado confirmatorio posterior.

Inyección Intraarticular Única de Ácido Hialurónico en la Artrosis de Rodilla: Estudio Multicéntrico Prospectivo Abierto (ART-ONE 75) mediante Comparación Post-Hoc con Placebo.

INTRODUCCIÓN: La viscosuplementación del líquido sinovial mediante la inyección intraarticular (IA) de ácido hialurónico (AH) es un tratamiento sintomático ampliamente utilizado en la artrosis de rodilla (AR). Además de los productos diseñados para realizar inyecciones múltiples (normalmente de 3 a 5 inyecciones, en intervalos de 1 semana), se presta especial atención a los productos de una única inyección, ya que ofrecen ventajas específicas, como son un menor número de visitas al médico y de intervenciones invasivas con sus riesgos asociados. Sin embargo, aún existen dudas sobre la eficacia de estas inyecciones únicas, en comparación con los regímenes de inyecciones múltiples. MÉTODOS: Se realizó un estudio multicéntrico, abierto, prospectivo, post-mercado (ART-ONE 75) con el producto de inyección única ARTHRUM 2,5% (3 ml, 75 mg AH), en 214 pacientes que sufrían de AR. Los pacientes fueron seguidos en D30, D60, D120 y D180 (días). El perfil promedio de los pacientes en el momento de la inclusión fue de 62,9 años, 56% mujeres, grados I-III de Kellgren-Lawrence (46% KL III), IMC de 27,2 kg/m2 y 4 años desde el diagnóstico de AR. Se realizó una comparación post-hoc con una inyección IA única de placebo (326 pacientes, agrupados de 3 estudios ECA), que proporcionaron un perfil de paciente similar. RESULTADOS: el criterio principal fue la variación desde el inicio de la puntuación de la escala WOMAC A (dolor, escala 0-100) en D60, que se redujo en 28,9 (17,4) para la población por intención de tratar (ITT, por sus siglas en inglés) (199 pacientes), 28,0 (17,8) para la población por protocolo (PP) en la inclusión (175 pacientes), y en 27,7 (16,8) para la población PP al finalizar (143 pacientes).Los criterios secundarios y accesorios incluyeron WOMAC A en otras ocasiones, WOMAC B (rigidez), WOMAC C (función), calidad de vida y discapacidad en cada momento de seguimiento. Todos los índices mejoraron significativamente y continuaron mejorando al final del estudio. La evaluación terapéutica en D180 mostró que más del 75% de los pacientes se encontraban satisfechos con la reducción del dolor, la mejora de la movilidad, y la reducción de analgésicos y AINE. El porcentaje de pacientes definidos como respondedores de OMERACT-OARSI fue superior al 86%, a partir de D60 y en adelante. La tolerancia general fue buena, sin que ocurriera ningún evento adverso grave. El resultado de la comparación post-hoc para la escala WOMAC A mostró un tamaño del efecto [IC 95%] desde TE = 0,33 [0,15; 0,51] en D60 a TE = 0,65 [0,45; 0,85] en D180 (p <0,001), frente a la inyección de placebo (solución salina), lo cual es un resultado clínicamente relevante a favor de ARTHRUM 2,5%. CONCLUSIÓN: El presente estudio confirma la eficacia clínica de una única inyección IA de 3 ml de solución de AH conteniendo 75 mg de AH nativo de alto PM (> 2 MDa).